Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis

Overview

The purpose of this study is to study the efficacy of denosumab, a new drug, in the treatment of osteoporosis in patients using bisphosphonates.

Full Title of Study: “Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2014

Detailed Description

There are no data on the use of denosumab in steroid induced osteoporosis. Postmenopausal women with chronic use of Glucocorticoid (GCs) are at high-risk of osteoporotic fractures. Despite bisphosphonate treatment, a certain proportion of high-risk patients using chronic GCs either do not achieve a satisfactory gain in bone mineral density (BMD) or develop new fragility fractures. Thus, more potent osteoporosis treatment is necessary for this subgroup of patients. This prompts the current study which aims to examine the efficacy of denosumab in current users of oral bisphosphonates for Glucocorticoid-induced Osteoporosis (GIOP).

Interventions

  • Drug: Denosumab
    • 60mg subcutaneous injection 6 monthly for 2 doses
  • Drug: bisphosphonates
    • continue present bisphosphonate treatment

Arms, Groups and Cohorts

  • Active Comparator: Denosumab
    • denosumab
  • Active Comparator: bisphosphonates
    • continuation of bisphosphonates

Clinical Trial Outcome Measures

Primary Measures

  • bone mineral density (BMD) changes at the lumbar spine
    • Time Frame: baseline, 6 months and 12 months

Secondary Measures

  • BMD changes in the total hip and femoral neck
    • Time Frame: baseline, 6 months and 12 months
  • bone turnover markers
    • Time Frame: baseline, 6 months and 12 months
  • New vertebral fractures
    • Time Frame: 12 months
  • adverse events
    • Time Frame: 12 months

Participating in This Clinical Trial

Inclusion Criteria

1. Women or adult men (>18 years of age) with various medical diseases requiring long-term prednisolone treatment. Pre-menopausal women should have no plan for pregnancy within 2 years of study entry and agree to practice contraception during this 2-year period. 2. A daily dose of prednisolone (or equivalent) of more than 2.5mg within 3 months of study entry. 3. Having received oral bisphosphonate treatment for at least 2 years. 4. Suboptimal response to bisphosphonate treatment, defined as either one of the following: (1) failure of lumbar spine, femoral neck or total hip BMD values to increase; (2) values of lumbar spine, femoral neck or total hip BMD remain osteoporotic, ie. T scores < -2.5 or Z scores < -2.0; or (3) development of new fragility vertebral or non-vertebral fractures despite at least 2 years' treatment with good compliance. 5. Informed consent from patients. Exclusion Criteria:

1. Patients with previous use of denosumab or teriparatide. 2. Premenopausal women who plan for pregnancy within 2 years of study entry or who do not agree for contraception within this 2-year period. 3. Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism. 4. Patients with unexplained hypocalcemia. 5. Patients with serum creatinine level of >=200umol/L.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tuen Mun Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Chi Chiu Mok, Consultant – Tuen Mun Hospital
  • Overall Official(s)
    • Chi Chiu Mok, MD, FRCP, Principal Investigator, Tuen Mun Hospital

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