Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis

Osteoporosis Clinical Trial

Official title:

Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01465568
• Other study ID #: CREC/984/11
• Status: Completed
• Phase: Phase 4
• First received: October 30, 2011
• Last updated: May 11, 2015
• Start date: December 2011
• Est. completion date: June 2014

Study information

• Verified date: May 2015
• Source: Tuen Mun Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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

Locations

Country	Name	City	State
China	Tuen Mun Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Tuen Mun Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone mineral density (BMD) changes at the lumbar spine		baseline, 6 months and 12 months	No
Secondary	BMD changes in the total hip and femoral neck		baseline, 6 months and 12 months	No
Secondary	bone turnover markers		baseline, 6 months and 12 months	No
Secondary	New vertebral fractures		12 months	No
Secondary	adverse events		12 months	Yes