Efficacy and Safety of Denosumab Compared With Risedronate in Individuals Taking Glucocorticoids

Phase 3

Completed

Conditions: Steroid-induced Osteopor, Glucocorticoid-induced Ostepor

Interventions: Drug: Risendronate
Drug: Denosumab
Drug: Placebo for risendronate
Drug: Placebo for denosumab

Registration Number: NCT01575873

Lead Sponsor: Amgen

Brief Summary: This is a 2-year study to evaluate the effect of denosumab versus risedronate in adults with glucocorticoid-induced osteoporosis.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 795

Inclusion Criteria

Men and women 18 years of age or older who have been taking glucocorticoid treatment. Men and women who are less than 50 years of age must have had a fracture as an adult to be eligible. Men and women who are 50 years of age or older who have been taking glucocorticoids must meet protocol-specific BMD criteria.

Exclusion Criteria

Use of agents affecting bone metabolism, use of more than one biologic agent for inflammatory disease, history of bone disease (except osteoporosis), low vitamin D level (one can enter the trial after vitamin D levels are corrected), abnormalities of blood calcium, an underactive or overactive thyroid condition that is not treated and stable, Addison's disease, any abnormality of the parathyroid glands (the glands that control blood calcium), currently pregnant or planning a pregnancy, currently breast feeding, and other criteria may apply.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Risendronate	Risendronate	Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
Denosumab	Placebo for risendronate	Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
Risendronate	Placebo for denosumab	Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
Denosumab	Denosumab	Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Non-inferiority Analysis)	Baseline and month 12	Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Superiority Analysis)	Baseline and month 12	Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).
Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 24	Baseline and month 24	Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).
Percent Change From Baseline in Total Hip Bone Mineral Density at Month 12	Baseline and month 12	Bone mineral density at the total hip was measured by dual-energy x-ray absorptiometry (DXA).
Percent Change From Baseline in Total Hip Bone Mineral Density at Month 24	Baseline and month 24	Bone mineral density at the total hip was measured by dual-energy x-ray absorptiometry (DXA).