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

Amgen

Status and phase: Completed; Phase 3

Conditions: Steroid-induced Osteopor, Glucocorticoid-induced Ostepor

Treatments: Drug: Placebo for risendronate; Drug: Risendronate; Drug: Placebo for denosumab; Drug: Denosumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01575873

20101217

2010-024393-19 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 795 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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795 participants in 2 patient groups

Denosumab

Experimental group

Description:

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.

Treatment:

Drug: Denosumab

Drug: Placebo for risendronate

Risendronate

Experimental group

Description:

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.

Treatment:

Drug: Placebo for denosumab

Drug: Risendronate