Table 2.

Summary of Inclusion and Exclusion Criteria for Each Trial

Trial	Inclusion	Exclusion	Clinicaltrials.gov identifiers
110	Postmenopausal women Aged 60–90 years BMD T‐score at lumbar spine or hip less than −2.5	Had conditions that influence bone metabolism Had taken oral bisphosphonates for more than 3 years If less than 3 years, they were eligible after 12 months without treatment Had used intravenous bisphosphonates, fluoride, or strontium for osteoporosis within the past 5 years Had used PTH or its derivatives, corticosteroids, systemic hormone‐replacement therapy, selective estrogen‐receptor modulators, or tibolone, calcitonin, or calcitriol within 6 weeks BMD T‐score at lumbar spine or hip less than −4.0 or any severe (or more than two moderate) prevalent vertebral fractures	NCT00089791
217	Ambulatory postmenopausal women BMD T‐score at lumbar spine between −1.0 and −2.5 Not receiving medication that affected bone metabolism (other than calcium and vitamin D supplements) Free from any underlying condition (other than low BMD) that might have resulted in abnormal bone metabolism Had no history of a fracture after the age of 25 years	Had received oral bisphosphonates for 3 or more years, cumulatively Those who had taken oral bisphosphonates for less than 3 months were eligible Those who had taken oral bisphosphonates for longer than 3 months but less than 3 years cumulatively were eligible after a 12‐month washout period Had received fluoride or strontium ranelate within 5 years Had received PTH or PTH derivatives, steroids, hormone‐replacement therapy, selective estrogen receptor modulators, tibolone, calcitonin, or calcitriol within 6 weeks	NCT00091793
318	Ambulatory men Aged 30–85 years BMD T‐score at lumbar spine or femoral neck between −2.0 and −3.5 or between −1.0 and −3.5 with a prior major osteoporotic fracture and had at least two lumbar vertebrae, one hip, and one forearm evaluable by DXA	Severe or >1 moderate vertebral fracture (using a semiquantitative grading scale) Any vertebral fracture or clinical fracture diagnosed within 6 months before screening Diseases that affect bone metabolism Vitamin D deficiency Had received bisphosphonate treatment for 3 months or more cumulatively in the past 2 years, for 1 month or more in the past year, or at any time during the 3‐month period before randomization Using anabolic steroids or testosterone, glucocorticoids, calcitonin, calcitriol, or vitamin D derivatives and other bone‐active drugs in a 3‐month period before screening A derived glomerular filtration rate <30 mL/min/1.73 m2	NCT00980174
419	Women Aged ≥ 18 years Early‐stage histologically or cytologically confirmed breast cancer that was hormone receptor–positive Undergoing adjuvant aromatase inhibitor therapy Completed treatment with surgery and/or radiation and chemotherapy ≥4 weeks BMD T‐score between −1.0 and −2.5 Serum 25‐hydroxyvitamin D levels ≥12 ng/mL	Prior vertebral fracture Current use of bisphosphonates Use of any antineoplastic therapy apart from aromatase inhibitors	NCT00089661
520	Men who had histologically confirmed prostate cancer Receiving androgen‐deprivation therapy with an expected duration of such treatment for 12 or more months Aged 70 years or older or younger than 70 years but had either a low BMD (T‐score less than −1.0) at baseline or a history of an osteoporotic fracture Eastern Cooperative Oncology Group performance status score of 2 or less	Concurrent receipt of antineoplastic therapy or radiotherapy PSA level of more than 5 ng per milliliter after receiving androgen‐deprivation therapy for more than 1 month Current use of oral bisphosphonates or previous exposure to oral bisphosphonates for 3 or more years or intravenous bisphosphonates within 5 years Those who had taken oral bisphosphonates for longer than 3 months but less than 3 years cumulatively were eligible if they had been free of oral bisphosphonates for ≥1 year BMD T‐score less than −4.0 Currently receiving treatment for osteoporosis	NCT00089674

BMD = bone mineral density; DXA = dual‐energy x‐ray absorptiometry; PSA = prostate‐specific antigen; PTH = parathyroid hormone.