Conditions: Low Bone Mineral Density
Keywords: bone loss osteoporosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 412
Healthy volunteers: no

Brief summary:
To determine the effect of denosumab treatment compared with placebo over 12 months on bone mineral density (BMD) of the lumbar spine in postmenopausal women with low BMD. The clinical hypothesis is that denosumab subcutaneous injections administered every 3 or 6 months for 12 months will significantly increase lumbar spine bone mineral density and will be well tolerated.

Detailed description:

Arms:
arm 1: Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42. arm 2: Participants received denosumab 6 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42. arm 3: Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42. arm 4: Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42. arm 5: Participants received denosumab 14 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42. arm 6: Participants received denosumab 60 mg SC every 6 months until Month 42. arm 7: Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42. arm 8: Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42. arm 9: Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.

Interventions: intervention 1: Placebo intervention 2: Denosumab intervention 3: Alendronate
Intervention descriptions: intervention 1: Placebo subcutaneous injection intervention 2: Denosumab for subcutaneous injection intervention 3: Alendronate 70 mg tablets

Protocol document: