Evidence Table C3. Quality Tables for Randomized Controlled Trials

Author, Year, Drug, Country, Trial nameRandomization adequate?Allocation concealment adequate?Groups similar at baseline?Eligibility criteria specified?Outcomes assessors masked?Care provider masked?Patient masked?Reporting of adherence and contamination?Loss to follow-up: differential/high?Intention-to-treat (ITT) analysis?Quality rating (Jadad score)Number screened/eligible/enrolledExclusion criteriaRun-in/WashoutClass naive patients only?Control group standard of care?FundingRelevance?
Agrawal S et al., 20061 Not describedNot describedYesYesNRYesYesYes/YesNoNo464/NR/60Carcinoma or suspected carcinoma, Metabolic bone disorder other than osteoporosis, Renal insufficiency, Med known to affect skeleton, age <65, any significant lab abnormalities, Osteoporotic fracture within 2yrsNRNot reportedYesSource: Industry; Role: describedLimited
RisedronateNR
US
Aris RM et al., 20002 YesNot describedYesYesYesNoNoNR/NRNoYes344/37/37Pregnancy, Renal insufficiency, Life expectancy <5 years, Graft FailureNRNot reportedYesSource: Government & Private; Role: NRLimited
PamidronateNR
US
Black DM et al., 20073 YesNot describedYesYesYesNRYes, but not describedYes/NRNRYes418421/9977/7765Bisphosphonates, Fluoride, Anabolic steroids, Corticoids/Glucocorticoids, Hypercalcemia, Hypocalcemia, previous PTH use, >2+ protein on urine dipstick, bisphosphonate use for >=48 weeks within 2 years prior to study, Growth Hormone use, strontium use, calculated creatinine clearance, 30.0 ml/minNRNoYesSource: Industry; Role: describedYes
Zoledronic acidNR
US, Canada, Latin Amer, Western Europe, Eastern Europe, Australia/NZ, Asia
Horizon
Body JJ et al., 20024 Not describedNot describedYesYesYes, but not describedYes, but not describedYes, but not describedYes/NRNoYes4265/149/149Age > 85, Carcinoma or suspected carcinoma, Hepatic insufficiency, Metabolic bone disorder other than osteoporosis, Renal insufficiency, Malabsorption syndrome, Urolithiasis, Bisphosphonates, Calcitonin, Fluoride, Androgen, Estrogen agonists (including estrogen), Anabolic steroids, Corticoids/Glucocorticoids, Alcohol Abuse, Allergy to PTH, age<30, LS spine abnormalities prohibiting DEXA, previous PTH useRun-in period reportedYesYesSource: Industry; Role: NRYes
Alendronate, PTHNR
US, Canada, Latin America, Western Europe, Israel
Bone HG et al., 20005 YesNot describedYesYesNRYes, but not describedYes, but not describedNR/NRNoYes4NR/NR/425Cardiovascular disease, Metabolic bone disorder other than osteoporosis, Renal insufficiency, Venous thromboembolic disease - Active, Venous thromboembolic disease - Ever, Bisphosphonates, Calcitonin, Fluoride, Vitamin D deficient, recent major upper GI mucosal erosive disease, Increased risk of breast cancer, Unexplained genital bleeding × 1 year, Fasting triglycerides >400mg/dL, Contraindication to HRT, HRT within last 6 monthsNRNot reportedNoSource: Industry; Role: NRYes
Alendronate, EstrogenNR
US
ALENDRONATE ESTROGEN STUDY GRP
Bonnick S et al., 20066 YesNot describedYesYesYesYesYesNR/NRNRYes41759/NR/1053Metabolic bone disorder other than osteoporosis, Upper GI, Bisphosphonates, Fluoride, HRT, Estrogen agonists (including estrogen), Anabolic steroids, Corticoids/Glucocorticoids, Vitamin D deficient, previous PTH use, Hypocalcemia, ImmunosuppressantsNRNot reportedYesSource: Industry; Role: NRYes
Alendronate, RisedronateNR
US
FACT
Boutsen Y et al., 19977 YesNot describedYesYesNRNRNRNR/NRNoNo3NR/NR/32Carcinoma or suspected carcinoma, Hypothyroidism, Hyperthyroidism, Hyperparathyroidism, Hepatic insufficiency, Renal insufficiency, Urolithiasis, Bisphosphonates, Fluoride, Previous GlucocorticoidsNRYesNoSource: Not reportedYes
PamidronateNR
Western Europe
Brown JP et al., 20028 Not describedNot describedYesYesYesYesYesYes/NRNRYes34972/NR/1468Med known to affect skeleton, LS spine abnormalities prohibiting DEXANRNot reportedYesSource: Industry; Role: NRYes
RisedronateNR
US, Canada
Campbell IA et al., 20049 YesNoYesYesNRNoNoNR/NRNoYes2NR/NR/352Hysterectomy, age <=50, age >=70NRNot reportedNoSource: Industry; Role: NRYes
EtidronateNR
UK
Chapurlat RD et al., 200510 YesYesNoYesYesYesYesYes/NRNRNo4NR/NR/1746Cardiovascular disease, Hypothyroidism, Hyperthyroidism, Hyperparathyroidism, Hepatic insufficiency, Renal insufficiency, Malabsorption syndrome, Upper GI, Bisphosphonates, Calcitonin, Fluoride, Estrogen agonists (including estrogen), age >= 80, age <=55, life expectancy =<3yrsNRYesYesSource: Industry; Role: NRYes
[Hip]NR
Alendronate
US
FIT
Chapurlat RD et al., 200510 YesYesNoYesYesYesYesYes/NRNRNo4NR/NR/1318Cardiovascular disease, Hypothyroidism, Hyperthyroidism, Hyperparathyroidism, Hepatic insufficiency, Renal insufficiency, Malabsorption syndrome, Upper GI, Bisphosphonates, Calcitonin, Fluoride, Estrogen agonists (including estrogen), age >= 80, age <=55, life expectancy =<3yrsNRYesYesSource: Industry; Role: NRYes
[Spine]NR
Alendronate
US
FIT
Chesnut CH et al., 200411 YesNot describedYesYesNRYesYesNR/NRNRYes418447/NR/2946Metabolic bone disorder other than osteoporosis, Renal insufficiency, Bisphosphonates, Fluoride, Med known to affect skeleton, Diseases known to affect skeleton, > 2 fractures lumbar spine, Contraindication to Ca or Vitamin D, Hypercalcemia, Hypocalcemia, age <=55, age >= 80, T score<-5.0NRYesYesSource: Industry; Role: NRYes
IbandronateNR
US, Canada, UK, Western Europe, Eastern Europe
BONE
Coco M et al., 200312 YesNot describedYesYesNRNRNRNR/NRNRNo2112/98/72PregnancyNRNot reportedYesSource: Not reportedYes
PamidronateNR
US
Cosman F et al., 200113 YesNot describedYesYesYesNRNRNR/NRNoNo3280/174/52Metabolic bone disorder other than osteoporosis, NephrolithiasisNRNot reportedYesSource: Government; Role: NRYes
Estrogen, PTHWashout period reported
US
Cosman F et al., 200514 YesNot describedYesYesYesNoNoYes/NRNoNo31345/131/126Hypothyroidism, Hyperthyroidism, Hyperparathyroidism, Hypoparathyroidism, Hepatic insufficiency, Metabolic bone disorder other than osteoporosis, Renal insufficiency, Nephrolithiasis, Anticonvulsants, Estrogen agonists (including estrogen), Corticoids/Glucocorticoids, Abnormal Urinary Calcium, Abnormal CBCNRNoNoSource: Government; Role: describedYes
Alendronate, PTHNR
US
Fisher B et al., 199815 YesYesNRYesNRYes, but not describedYes, but not describedNR/NRNoNo398018/13954/13388Pregnancy, Hepatic insufficiency, Renal insufficiency, Venous thromboembolic disease, Estrogen agonists (including estrogen), Progestin, Contraceptive, Breast Cancer, Abnormal CBCNRNot reportedYesSource: Government; Role: NRYes
TamoxifenNR
US, Canada
NSABP-P1
Fukunaga M et al., 200216 Not describedNot describedYesYesYesYesYesNR/NRNoNo3362/NR/235Age > 75, Carcinoma or suspected carcinoma, Cardiovascular disease, Hepatic insufficiency, Metabolic bone disorder other than osteoporosis, Renal insufficiency, Upper GI, LS spine abnormalities prohibiting DEXA, Med known to affect skeleton, Drug Hypersensitivity, History of RadiotherapyNRNot reportedNoSource: Industry; Role: NRYes
Etidronate, RisedronateNR
Japan
RESIDRONATE PHASE III RESEARCH
Gallagher JC et al., 200517 Not describedNot describedYesYesYesYes, but not describedYes, but not describedNR/NRNRNo29347/NR/931Hepatic insufficiency, Renal insufficiency, Urolithiasis, nonambulatory, Alcohol Abuse, drug abuse, any medication that may alter bone and mineral metabolism, illnesses that affect bone and calcium metabolismNRNot reportedYesSource: Industry; Role: NRYes
PTHNR
US, Canada, Latin Amer, Western Europe, Eastern Europe, Australia/NZ, Finland, Denmark, Italy, Israel
FRACTURE PREVENTION TRIAL
Garcia-Delgado I et al., 199718 Not describedNot describedYesYesNRNRNRNR/NRNRYes1NR/NR/40Med known to affect skeleton, HypogonadismNRNot reportedYesSource: Government; Role: NRNo
Calcitonin, EtidronateNR
Western Europe
Grant AM et al., 200519 YesYesYesYesYesYesYesYes/NRNRYes415024/8827/5292Carcinoma or suspected carcinoma, Nephrolithiasis, Bisphosphonates, Calcitonin, Calcium (includes antacids), Fluoride, HRT, SERMS, Vitamin D, age < 70, nonambulatory, mental condition that would preclude participation, Hypercalcemia, life expectancy <1/2 years, fracture associated with bone abnormalityNRNot reportedNoSource: Government & Industry; Role: describedYes
Vitamin DNR
UK
Greenspan SL et al., 200320 YesYesYesYesYesYesYesNR/NRNoYes5573/548/373Carcinoma or suspected carcinoma, Hyperthyroidism, Hyperparathyroidism, Hepatic insufficiency, Renal insufficiency, Anticonvulsants, Bisphosphonates, Calcitonin, Hormone use, Corticoids/Glucocorticoids, Med known to affect skeleton, Contraindication to HRT, Contraindication to alendronate, BMD hip T score >0.0Run-in period reportedNot reportedYesSource: Government; Role: describedYes
Alendronate, EstrogenNR
US
Greenspan SL et al., 200621 YesYesYesYesYesYesYesYes/NRNoYes5106/94/87Carcinoma or suspected carcinoma, Hyperparathyroidism, Hepatic insufficiency, Metabolic bone disorder other than osteoporosis, Renal insufficiency, Malabsorption syndrome, age <18, Stage IV breast cancer, any medication that may alter bone and mineral metabolismNRNot reportedYesSource: 11110; Role: describedYes
RisedronateNR
US
Grotz W et al., 200122 Not describedNoYesYesYesNRNoYes/NRNoNo2114/98/80Kidney Pancreas TransplantNRNot reportedNoSource: Not reportedLimited
IbandronateNR
Germany
Guanabens N et al., 200323 YesNot describedYesYesYesNRNRNR/NRNoNo3NR/NR/32Renal insufficiency, Upper GI, Bisphosphonates, Fluoride, Estrogen agonists (including estrogen), Corticoids/Glucocorticoids, Bilirubin >10mg/dLNRYesYesSource: Government; Role: describedNo
Alendronate, EtidronateNR
Western Europe
Harris ST et al., 200124 Not describedNot describedYesYesNRNRNRYes/NRNRYes2NR/NR/524Metabolic bone disorder other than osteoporosis, HRT, Med known to affect skeleton, Major systemic Disease, Abnormal Pap, Significant Psychiatric disease, LS spine abnormalities prohibiting DEXANRNot reportedYesSource: Industry; Role: NRYes
Estrogen, RisedronateNR
US
Harris ST et al., 200425 Not describedNot describedYesYesYesYesYesYes/NRNoYes34972/NR/1468Med known to affect skeleton, LS spine abnormalities prohibiting DEXANRNot reportedYesSource: Industry; Role: NRYes
RisedronateNR
US, Canada
Hay JE et al., 200126 Not describedNoYesYesNRNoNoNR/YesNRYes1NR/NR/63Hypothyroidism, Hyperthyroidism, Metabolic bone disorder other than osteoporosis, Renal insufficiency, Anticonvulsants, Hormone use, Corticoids/Glucocorticoids, Med known to affect skeleton, Survived 6mos after liver transplantNRNot reportedYesSource: Industry; Role: NRYes
CalcitoninNR
US
Henderson S et al., 200627 YesYesYesYesYesYesYesNR/NRNoNo5NR/NR/61Pregnancy, Hepatic insufficiency, Bisphosphonates, HRT, Vitamin D deficient, Osteoporotic fracture, breast feeding, Hypercalcemia, HypocalcemiaNRYesYesSource: Industry; Role: NRYes
RisedronateNR
Australia/NZ
Hizmetli S et al., 199828 Not describedNoYesYesNRNoNoNR/NRNRNo1NR/NR/107Med known to affect skeleton, Secondary OsteoporosisNRYesYesSource: Not reportedYes
CalcitoninNR
Turkey
Hochberg MC et al., 200529 YesYesYesYesYesYesYesNR/NRNRYes4NR/NR/3658Cardiovascular disease, Hypothyroidism, Hyperthyroidism, Hyperparathyroidism, Hepatic insufficiency, Renal insufficiency, Malabsorption syndrome, Upper GI, Bisphosphonates, Calcitonin, Fluoride, Estrogen agonists (including estrogen), age >= 80, age <=55, life expectancy =<3yrsNRYesYesSource: Industry; Role: NRYes
AlendronateNR
US
FIT
Hodsman AB et al., 199730 Not describedNot describedYesYesNRNRNRNR/NRNoNo2NR/NR/39Endocrine disease, Metabolic bone disorder other than osteoporosis, Bisphosphonates, Calcitonin, Corticoids/GlucocorticoidsNRNot reportedNoSource: Government & Industry; Role: NRYes
Calcitonin, RaloxifeneNR
Canada
Hooper MJ et al., 200531 YesNot describedYesYesNRNRNRNR/NRNoYes3NR/NR/383Hyperthyroidism, Hyperparathyroidism, Metabolic bone disorder other than osteoporosis, Serum estradiol >20, Med known to affect skeletonNRNot reportedNoSource: Industry; Role: NRYes
RisedronateNR
Australia/NZ
Hosking D et al., 200332 YesYesYesYesNRYesYesNR/NRNoYes51036/NR/549Hypothyroidism, Hyperthyroidism, Hyperparathyroidism, Metabolic bone disorder other than osteoporosis, Bisphosphonates, Fluoride, HRT, Estrogen agonists (including estrogen), Corticoids/Glucocorticoids, LS spine abnormalities prohibiting DEXA, Vitamin D deficient, Severe Upper GI symptoms, Severe Osteoporosis, age >90, age <60, Abnormal Urinary CalciumNRNot reportedNoSource: Industry; Role: NRYes
Alendronate, RisedronateNR
UK, Western Europe, Brazil
Ishida Y et al., 200433 Not describedNot describedYesYesYesNRNRNR/NRNoYes2739/NR/396Age > 75, Carcinoma or suspected carcinoma, Metabolic bone disorder other than osteoporosis, Med known to affect skeleton, bilateral hip fractures, mental condition that would preclude participationNRNot reportedNoSource: Not reportedYes
Calcitonin, Estrogen, EtidronateNR
Japan
YAMAGUCHI OP PREVENTION STUDY
Iwamoto J et al., 200334 Not describedNot describedYesYesNRNRNoNR/NRNoYes1NR/NR/50Metabolic bone disorder other than osteoporosis, HRT, Estrogen agonists (including estrogen), Med known to affect skeletonNRYesNoSource: Not reportedYes
Alendronate, EtidronateNR
Japan
Iwamoto J et al., 200335 Not describedNot describedYesYesNRNRNoNR/NRNRNo1NR/NR/40Metabolic bone disorder other than osteoporosis, HRT, Estrogen agonists (including estrogen), Med known to affect skeleton, any lumbar vertebral fracturesNRYesNoSource: Not reportedYes
Alendronate, EtidronateNR
Japan
Jackson RD et al., 200636 YesNot describedYesYesYesYesYesYes/YesNoYes468132/62528/36282Nephrolithiasis, Vitamin D, Corticoids/Glucocorticoids, age >= 80, Hypercalcemia, age <=50, life expectancy =<3yrsNRNoYesSource: Government & Industry; Role: describedYes
Calcium, Vitamin DNR
US
WHI
Kanaji A et al., 200637 Not describedNot describedYesYesNRYesYesNR/NRNRNo4NR/NR/23any medication that may alter bone and mineral metabolismNRNot reportedYesSource: Not reportedLimited
RisedronateNR
Japan
Kananen K et al., 200538 Not describedNot describedYesYesNRNoNoNR/YesNoNo1115/108/99Renal insufficiency, MyelomaNRNot reportedYesSource: Hospital, Industry & Private; Role: NRLimited
Estrogen, Pamidronate, TestosteroneNR
Finland
Kaufman JM et al., 200539 YesNot describedYesYesNRYesNRYes/NRNRNo4959/437/355Age > 85, Carcinoma or suspected carcinoma, Hyperparathyroidism, Hypoparathyroidism, Hepatic insufficiency, Metabolic bone disorder other than osteoporosis, Renal insufficiency, Sprue, Inflammatory bowel disease, Malabsorption syndrome, Nephrolithiasis, Urolithiasis, Anticonvulsants, Aluminum, Bisphosphonates, Calcitonin, Calcium (includes antacids), Coumarins, Fluoride, Androgen, Estrogen agonists (including estrogen), Progestin, Estrogen antagonists, Anabolic steroids, Vitamin D, Corticoids/Glucocorticoids, Abnormal Urinary Calcium, nonambulatory, any medication that may alter bone and mineral metabolism, treatment with calcitriol analogues, age<30, Secondary Osteoporosis, Alcohol Abuse, LS spine abnormalities prohibiting DEXA, treatment with indandione derivatives, Hypercalcemia, Hypocalcemia, Major systemic Disease, drug abuse, Growth Hormone deficiency, poor intestinal calcium absorptionRun-in period reportedNot reportedYesSource: Industry; Role: NRYes
PTHNR
US, Canada, Australia/NZ, Netherlands, Italy, Belgium, France, Spain, Sweden
Kim SH et al., 200440 Not describedNot describedYesYesNRNRNRNR/NRNoYes2NR/NR/50Renal insufficiency, Bisphosphonates, bed restNRNot reportedYesSource: Unclear; Role: NRLimited
PamidronateNR
Asia
Kishimoto H et al., 200641 Not describedNot describedYesYesYesYesYesNR/NRNoYes3NR/NR/496Carcinoma or suspected carcinoma, Cardiovascular disease, Hepatic insufficiency, Metabolic bone disorder other than osteoporosis, Renal insufficiency, Gastrointestinal disease, Bisphosphonates, any medication that may alter bone and mineral metabolism, Drug Hypersensitivity, radiation therapy to lumbar spine or pelvis, LS spine abnormalities prohibiting DEXANRNot reportedYesSource: Industry; Role: NRYes
RisedronateNR
Japan
Kushida K et al., 200442 Not describedNot describedYesYesYesNRYesNR/NRNoNo4NR/NR/547Cardiovascular disease, Hepatic insufficiency, Metabolic bone disorder other than osteoporosis, Renal insufficiency, Gastrointestinal disease, treatment with Risedronate or etidronate, Secondary Osteoporosis, radiographic findings that affect vertebral intensity, Med known to affect skeleton, malignancy under treatment with anti-tumor agents, radiation therapy to lumbar spine or pelvisNRNot reportedYesSource: Industry & Private; Role: NRYes
Etidronate, RisedronateNR
Japan
RESIDRONATE PHASE III RESEARCH III RESEARCH GROUP
Lindsay R et al., 199743 YesYesYesYesYesNRNoYes/NRNoYes3NR/NR/40Hypothyroidism, Hyperthyroidism, Hepatic insufficiency, Renal insufficiency, Nephrolithiasis, Secondary OsteoporosisRun-in period reportedNot reportedNoSource: Government & Industry; Role: describedYes
Estrogen, PTHNR
US
Lindsay R et al., 199944 Not describedNot describedYesYesNRNRNRNR/NRNoYes11855/565/428Hyperthyroidism, Metabolic bone disorder other than osteoporosis, Upper GI, Bisphosphonates, CalcitoninRun-in period reportedNot reportedYesSource: Industry; Role: NRYes
Alendronate, EstrogenNR
US
Luckey M et al., 200445 YesYesYesYesYesNRYesNR/NRNoYes51200/508/456Hepatic insufficiency, Metabolic bone disorder other than osteoporosis, Upper GI, Venous thromboembolic disease - Active, Venous thromboembolic disease - Ever, Bisphosphonates, Fluoride, Estrogen agonists (including estrogen), SERMS, Anabolic steroids, Corticoids/Glucocorticoids, LS spine abnormalities prohibiting DEXA, Immunosuppressants, Hypocalcemia, previous PTH use, Med known to affect skeleton, Breast Cancer, Uterine CancerNRNot reportedYesSource: Industry; Role: NRYes
Alendronate, RaloxifeneNR
US
THE EFFECT STUDY
McClung MR et al., 200646 YesNot describedYesYesYesNoNoNR/NRNRYes2NR/NR/412Hypothyroidism, Hyperthyroidism, Hyperparathyroidism, Hypoparathyroidism, Metabolic bone disorder other than osteoporosis, Renal insufficiency, Malabsorption syndrome, Bisphosphonates, Calcitonin, Fluoride, Androgen, Estrogen agonists (including estrogen), SERMS, Estrogen antagonists, Testosterone, Vitamin D, Corticoids/Glucocorticoids, age >= 80, Hypocalcemia, LS spine abnormalities prohibiting DEXA, previous PTH use, Long bone fracture, greater than one vertebral fracture, Osteoporotic fracture within 2yrsNRNot reportedYesSource: Industry; Role: describedYes
Alendronate, AMG162NR
US
Milgrom C et al., 200447 Not describedNot describedYesYesNRYesYesYes/YesNoYes4473/473/324NRNRNot reportedYesSource: Government & Industry; Role: NRLimited
RisedronateNR
Israel
Muscoso E et al., 200448 Not describedNot describedNRYesNRNoNoNR/NRNRNo1NR/NR/2000NRNRNot reportedYesSource: Not reportedYes
Alendronate, Raloxifene, RisedronateNR
Italy
Ninkovic M et al., 200249 YesYesYesYesYesYesNoYes/YesNoNo2NR/NR/99Renal insufficiency, Bisphosphonates, retransplantationNRYesNoSource: Not reportedLimited
PamidronateNR
UK
Orwoll ES et al., 200350 YesYesYesYesNRYesYesYes/NRNRYes4959/NR/437Age > 85, Carcinoma or suspected carcinoma, Hyperparathyroidism, Hypoparathyroidism, Hepatic insufficiency, Metabolic bone disorder other than osteoporosis, Renal insufficiency, Sprue, Inflammatory bowel disease, Malabsorption syndrome, Nephrolithiasis, Urolithiasis, Anticonvulsants, Aluminum, Bisphosphonates, Calcitonin, Calcium (includes antacids), Coumarins, Fluoride, Estrogen agonists (including estrogen), Progestin, Estrogen antagonists, Anabolic steroids, Vitamin D, Corticoids/Glucocorticoids, age<30, Med known to affect skeleton, Alcohol Abuse, drug abuse, LS spine abnormalities prohibiting DEXA, Growth Hormone deficiency, treatment with indandione derivativesNRYesYesSource: Industry; Role: NRYes
PTHNR
1100101000
Palomba S et al., 200551 YesNot describedYesYesYesYesYesNR/NRNoNo4279/97/90Carcinoma or suspected carcinoma, Endocrine disease, Hyperparathyroidism, Hepatic insufficiency, Metabolic bone disorder other than osteoporosis, Renal insufficiency, Bisphosphonates, Calcitonin, Fluoride, HRT, Anabolic steroids, Proton pump inhibitors, Corticoids/Glucocorticoids, Vitamin D deficient, Hypercalcemia, Hypocalcemia, Med known to affect skeleton, hydrochlorothiazide, active rheumatoid arthritis, tobacco abuse, extremes of BMI (either high or low), other medications that could cause GI irritationNRNot reportedYesSource: Not reportedYes
RisedronateNR
Italy
Porthouse J et al., 200552 YesYesYesYesNoNoNoYes/YesNRYes211022/7944/3454Renal insufficiency, Nephrolithiasis, Urolithiasis, Calcium (includes antacids), age < 70, unable to give informed consent, Hypercalcemia, life expectancy <1/2 yearsNRNot reportedNoSource: Government & Industry; Role: describedYes
Calcium, Vitamin DNR
UK
Prince RL et al., 200653 YesYesYesYesNRYesYesYes/NRNRYes54312/1510/1460age < 70, participation in another trial, Med known to affect skeleton, Life expectancy <5 yearsNRNot reportedNoSource: Government; Role: describedYes
CalciumNR
Australia/NZ
Quandt SA et al., 200554 YesNot describedYesYesYesYesYesYes/NRNRNo4NR/NR/3737Carcinoma or suspected carcinoma, Cardiovascular disease, Hyperparathyroidism, Hypoparathyroidism, Metabolic bone disorder other than osteoporosis, Renal insufficiency, Malabsorption syndrome, Upper GI, Bisphosphonates, Calcitonin, Fluoride, Estrogen agonists (including estrogen), Progestin, Anabolic steroids, Corticoids/Glucocorticoids, BMD femoral neck < -3, noncompliance, history of bilateral hip replacement, nonambulatory, Alcohol Abuse, age <=55, age >= 80, Major systemic Disease, intending to move within four years, any vertebral deformity, recent major upper GI mucosal erosive disease, participation in another trial, unable to give informed consent, change in thyroid hormone dose, unexpected weight loss > 10% of ideal body weight in last 12 monthsNRNoNoSource: Industry; Role: NRYes
AlendronateNR
US
FIT
Ravn P et al., 199655 Not describedNot describedYesYesNRNRNRNR/NRNoNo3NR/821/180Age > 75, Bisphosphonates, Calcitonin, HRT, Diseases, conditions or treatments known to interfere with calcium metabolismNRNot reportedYesSource: Not reportedYes
IbandronateNR
Western Europe
Recker R et al., 200456 YesNot describedYesYesYesYes, but not describedYes, but not describedNR/NRNoNo316632/NR/2862Carcinoma or suspected carcinoma, Hypothyroidism, Hyperthyroidism, Hyperparathyroidism, Hepatic insufficiency, Metabolic bone disorder other than osteoporosis, Renal insufficiency, Gastrointestinal disease, Bisphosphonates, Calcitonin, Fluoride, HRT, Corticoids/Glucocorticoids, Alcohol Abuse, Med known to affect skeleton, Hypercalcemia, Hypocalcemia, Contraindication to Ca or Vitamin D, CyclosporineNRNot reportedYesSource: Industry; Role: NRYes
IbandronateNR
US, Western Europe
Recker RR et al., 200657 YesYesYesYesYesYesYesYes/NRNoYes45531/1840/1423Hypothyroidism, Hyperthyroidism, Hyperparathyroidism, Hypoparathyroidism, Hepatic insufficiency, Metabolic bone disorder other than osteoporosis, Renal insufficiency, Upper GI, Venous thromboembolic disease, Bisphosphonates, Calcitonin, Fluoride, Androgen, Estrogen agonists (including estrogen), Progestin, SERMS, Estrogen antagonists, Anabolic steroids, Testosterone, Vitamin D, Corticoids/Glucocorticoids, any medication that may alter bone and mineral metabolism, Breast Cancer, previous PTH use, vaginal bleeding, age <=50, age > 80, T score<-4.0, fracture T4 to L4NRNot reportedYesSource: Industry; Role: describedYes
Alendronate, RaloxifeneNR
US, Canada
EVA trial
Reginster JY et al., 200658 YesYesYesYesNRYesYesYes/NRNoYes42410/NR/1609Metabolic bone disorder other than osteoporosis, Renal insufficiency, Upper GI, Bisphosphonates, Fluoride, age > 80, Contraindication to Ca or Vitamin DNRYesYesSource: Industry; Role: NRYes
IbandronateNR
US, Canada, Latin Amer, UK, Western Europe, Eastern Europe, Australia/NZ, South Africa
MOBILE
Reid IR et al., 199459 Not describedNot describedYesYesNRYesYesYes/NRNoNo4NR/NR/61Hypothyroidism, Hyperthyroidism, Hepatic insufficiency, Renal insufficiency, Anticonvulsants, Bisphosphonates, Calcitonin, Fluoride, HRT, Anabolic steroids, Corticoids/Glucocorticoids, Major systemic Disease, Hypercalcemia, HypocalcemiaNRYesNoSource: Government, Industry & Private; Role: NRYes
PamidronateNR
Australia/NZ
Reid IR et al., 200260 Not describedYesYesYesYesYesYesNR/NRNRYes3NR/NR/351Carcinoma or suspected carcinoma, Hypothyroidism, Hyperthyroidism, Hyperparathyroidism, Hypoparathyroidism, Hepatic insufficiency, Metabolic bone disorder other than osteoporosis, Renal insufficiency, Bisphosphonates, Fluoride, HRT, Estrogen agonists (including estrogen), >1 Fracture, Vitamin D deficient, Med known to affect skeletonNRYesNoSource: Industry; Role: describedYes
Zoledronic acidNR
Western Europe, Australia
Reid IR et al., 200461 YesNot describedYesYesYesNRNRNR/NRNoYes2NR/1522/619Hepatic insufficiency, Renal insufficiency, Venous thromboembolic disease - Ever, Anticonvulsants, Bisphosphonates, Calcitonin, Fluoride, Androgen, Estrogen agonists (including estrogen), Progestin, Lipid lowering agents, Vitamin D, Corticoids/Glucocorticoids, age <40, Endocrine disease requiring treatment except thyroid, FSH<40, excessive alcohol intake, >60 years, Breast Cancer, Estrogen Dependent CA, Any cancer except skin in last 5 years, Serious postmenopausal symptomsNRNoNoSource: Industry; Role: NRYes
Estrogen, RaloxifeneNR
US, Canada, Western Europe, Australia/NZ, South Africa
Reid IR et al., 200662 YesYesYesYesNRYesYesYes/NRNoYes42421/1780/1471Carcinoma or suspected carcinoma, Hypothyroidism, Hyperthyroidism, Hepatic insufficiency, Metabolic bone disorder other than osteoporosis, Renal insufficiency, Bisphosphonates, Calcium (includes antacids), HRT, Anabolic steroids, Corticoids/Glucocorticoids, age <=55, Med known to affect skeleton, Vitamin D deficientNRNot reportedYesSource: Unclear; Role: NRYes
CalciumNR
Australia/NZ
Ringe JD et al., 200663 Not describedNot describedYesYesYesNoNoNR/NRNRYes1580/NR/316Renal insufficiency, Bisphosphonates, Fluoride, Hypocalcemia, Drug HypersensitivityNRNot reportedYesSource: Not reportedYes
RisedronateNR
Germany
Rosen CJ et al., 200564 YesNot describedYesYesYesYesYesNR/NRNoYes41759/NR/1053Metabolic bone disorder other than osteoporosis, Upper GI, Bisphosphonates, Fluoride, HRT, Estrogen agonists (including estrogen), Anabolic steroids, Corticoids/Glucocorticoids, Immunosuppressants, previous PTH use, Inability to remain 30min upright, Vitamin D deficientNRNot reportedYesSource: Industry; Role: NRYes
Alendronate, RisedronateNR
US
FOSAMAX ACTONEL COMPARISON TRI
Sato S et al., 200365 Not describedNot describedYesYesYesNoNoNR/NRNRYes1NR/NR/102Cardiovascular disease, Renal insufficiency, Med known to affect skeleton, LS spine abnormalities prohibiting DEXANRNot reportedYesSource: Not reportedYes
EtidronateNR
Japan
Sato Y et al., 200466 YesNot describedNRYesNRYes, but not describedYes, but not describedNR/NRNRNo4NR/NR/80Cardiovascular disease, Hypothyroidism, Hyperthyroidism, Renal insufficiency, Bisphosphonates, Calcitonin, Estrogen agonists (including estrogen), Vitamin D, Corticoids/Glucocorticoids, nonambulatory, Underlying neurologic disorder, Prior calcium useNRNot reportedNoSource: Not reportedLimited
EtidronateNR
Japan
Sato Y et al., 200567 YesYesYesYesNRNRNRYes/NRNoYes4312/287/280Cardiovascular disease, Hypothyroidism, Hyperthyroidism, Hyperparathyroidism, Hepatic insufficiency, Metabolic bone disorder other than osteoporosis, Renal insufficiency, Upper GI, >1 Fracture, Familial Osteoporosis, Use of any drug known to alter bone metabolism for 3 months or longer during the preceding 12 monthsNRNot reportedNoSource: Not reportedYes
RisedronateNR
Japan
Sato Y et al., 200568 YesYesYesYesYesYesYes, but not describedYes/NRNoYes4658/510/500Cardiovascular disease, Hypothyroidism, Hyperthyroidism, Hyperparathyroidism, Hepatic insufficiency, Metabolic bone disorder other than osteoporosis, Renal insufficiency, Anticonvulsants, Bisphosphonates, Calcitonin, Calcium (includes antacids), Estrogen agonists (including estrogen), Vitamin D, Corticoids/Glucocorticoids, age < 70, treatment with Vitamin K, Familial OsteoporosisNRNot reportedYesSource: Not reportedYes
RisedronateNR
Japan
Sato Y et al., 200569 YesYesYesYesYesYesYesNR/NRNRNo4137/NR/96Cardiovascular disease, Hypothyroidism, Hyperthyroidism, Hepatic insufficiency, Metabolic bone disorder other than osteoporosis, Renal insufficiency, Anticonvulsants, Calcium (includes antacids), Vitamin D, dementia, total disability, hospitalization less than 2yrs, history of previous fracture, Drugs affecting Vitamin D Metabolism, Use of any drug known to alter bone metabolism for 3 months or longer during the preceding 12 monthsNRNot reportedNoSource: Not reportedYes
Vitamin DNR
Japan
Sato Y et al., 200570 YesNoYesYesNRYes, but not describedYes, but not describedNR/NRNoNo4NR/NR/374Cardiovascular disease, Hepatic insufficiency, Renal insufficiency, age <65, Med known to affect skeleton, mental condition that would preclude participation, inability to stand, quadraparesis, artificial nutritionNRYesNoSource: Not reportedYes
RisedronateNR
Japan
Sato Y et al., 200571 YesYesYesYesYesNRNoNR/NRNRNo2NR/NR/200Cardiovascular disease, Hypothyroidism, Hyperthyroidism, Hyperparathyroidism, Renal insufficiency, Bisphosphonates, Calcitonin, Calcium (includes antacids), Estrogen agonists (including estrogen), Vitamin D, Corticoids/Glucocorticoids, age < 70, treatment with Vitamin K, nonambulatory, Diseases known to affect skeleton, nonvertebral fractureNRNot reportedNoSource: Not reportedYes
Calcium, Vitamin DNR
Japan
Sato Y et al., 200672 YesYesYesYesYesNRYesNR/NRNoYes5558/NR/288Cardiovascular disease, Hypothyroidism, Hyperthyroidism, Hyperparathyroidism, Hepatic insufficiency, Metabolic bone disorder other than osteoporosis, Renal insufficiency, Bisphosphonates, Calcitonin, Calcium (includes antacids), Estrogen agonists (including estrogen), Vitamin D, Corticoids/Glucocorticoids, treatment with Vitamin K, nonvertebral fracture, Stage 5 Parkinson'sNRNot reportedNoSource: Not reportedYes
AlendronateNR
Japan
Sato Y et al., 200673 YesYesYesYesYesYesYesNR/NRNoYes485/NR/82Med known to affect skeletonNRNot reportedYesSource: Not reportedYes
EtidronateNR
Japan
Sorensen OH et al., 200374 Not describedNot describedYesYesYesYes, but not describedYes, but not describedNR/NRNRNo24400/NR/1226Age > 85, Bisphosphonates, Calcitonin, Fluoride, Hormone use, Estrogen agonists (including estrogen), Progestin, Anabolic steroids, Vitamin D, LS spine abnormalities prohibiting DEXA, any medication that may alter bone and mineral metabolism, noncomplianceNRNot reportedYesSource: Industry; Role: NRYes
RisedronateNR
UK, Western Europe, Eastern Europe, Australia/NZ
VERT
Tauchmanova L et al., 200675 Not describedNot describedYesYesNRNRNoNR/NRNoYes1NR/NR/60NRNRYesYesSource: Government; Role: NRYes
Estrogen, Risedronate, Zoledronic acidNR
Italy
Torres A et al., 200476 Not describedNot describedYesYesNRYesYesNR/NRNoNo4NR/NR/90previous parathyroidectomyNRNot reportedYesSource: Government; Role: NRYes
Calcium, Vitamin DNR
Spain
Toth E et al., 200577 Not describedNot describedYesYesNRNoNoNR/NRNoYes1225/75/71Carcinoma or suspected carcinoma, Endocrine disease, Hypothyroidism, Hyperthyroidism, Hyperparathyroidism, Hypoparathyroidism, Hepatic insufficiency, Metabolic bone disorder other than osteoporosis, Renal insufficiency, Malabsorption syndrome, Upper GI, Anticonvulsants, Bisphosphonates, Anabolic steroids, Vitamin D, Corticoids/Glucocorticoids, treatment with monofluorophosphate, any vertebral deformity, Secondary Osteoporosis, Hypogonadism, any significant lab abnormalities, any medication that may alter bone and mineral metabolismNRNot reportedNoSource: Not reportedYes
CalcitoninNR
Eastern Europe
Trovas GP et al., 200278 Not describedNot describedYesYesNRYesYesNR/NRNoYes4NR/NR/28Metabolic bone disorder other than osteoporosis, Secondary OsteoporosisNRNot reportedNoSource: Industry; Role: NRYes
CalcitoninNR
Greece
Uchida S et al., 200579 YesYesYesYesYes, but not describedYes, but not describedYes, but not describedNR/NRNRNo3NR/NR/328Bisphosphonates, >1 FractureNRNot reportedYesSource: Not reportedYes
AlendronateNR
Japan
Ushiroyama T et al., 200180 Not describedNoYesYesNRNoNoNR/NRNRYes1NR/NR/202Metabolic bone disorder other than osteoporosis, Renal insufficiency, Urolithiasis, HRT, Estrogen agonists (including estrogen), ContraceptiveNRNot reportedNoSource: Not reportedYes
CalcitoninNR
Japan
Vogel VG et al., 200681 YesNot describedNRYesYes, but not describedYes, but not describedYes, but not describedYes/NRNoYes3184460/20168/19747Carcinoma or suspected carcinoma, Diabetes, Venous thromboembolic disease - Ever, Coumarins, Androgen, HRT, Estrogen agonists (including estrogen), Progestin, Estrogen antagonists, Contraceptive, age <35, mental condition that would preclude participation, cholestyramine, Uncontrolled HTN, atrial fibrillation, preformance status restricting activityNRNot reportedYesSource: Government & Industry; Role: describedYes
Raloxifene, TamoxifenNR
US, Canada
STAR P-2
Wimalawansa SJ, 199882 YesYesYesYesYesNRNoNR/NRNoNo3350/NR/72Metabolic bone disorder other than osteoporosis, Bisphosphonates, Calcitonin, Fluoride, HRT, Anabolic steroids, Corticoids/Glucocorticoids, oopherectomy, Med known to affect skeletonNRYesYesSource: Not reportedYes
Estrogen, EtidronateNR
UK
Zein CO et al., 200583 YesNoYesYesYesYesYesNR/NRNoNo5NR/NR/34Hypothyroidism, Hyperthyroidism, Hyperparathyroidism, Renal insufficiency, Upper GI, Anticonvulsants, Calcitonin, Fluoride, Testosterone, Vitamin D, Corticoids/Glucocorticoids, heparin, Med known to affect skeleton, Vitamin D deficient, age >=70, age <18, starting estrogen within one year or discontinuing estrogen in the pastNRNot reportedYesSource: Industry; Role: NRYes
AlendronateNR
US

From: Appendix C, Evidence Tables

Cover of Comparative Effectiveness of Treatments To Prevent Fractures in Men and Women With Low Bone Density or Osteoporosis
Comparative Effectiveness of Treatments To Prevent Fractures in Men and Women With Low Bone Density or Osteoporosis [Internet].
Comparative Effectiveness Reviews, No. 12.
MacLean C, Alexander A, Carter J, et al.

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