Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis
This study is currently recruiting participants.
Verified October 2012 by Tuen Mun Hospital
Sponsor:
Tuen Mun Hospital
Information provided by (Responsible Party):
Chi Chiu Mok, Tuen Mun Hospital
ClinicalTrials.gov Identifier:
NCT01465568
First received: October 30, 2011
Last updated: October 29, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to study the efficacy of denosumab, a new drug, in the treatment of osteoporosis in patients using bisphosphonates.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoporosis |
Drug: Denosumab Drug: bisphosphonates |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis: a Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by Tuen Mun Hospital:
Primary Outcome Measures:
- bone mineral density (BMD) changes at the lumbar spine [ Time Frame: baseline, 6 months and 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- BMD changes in the total hip and femoral neck [ Time Frame: baseline, 6 months and 12 months ] [ Designated as safety issue: No ]
- bone turnover markers [ Time Frame: baseline, 6 months and 12 months ] [ Designated as safety issue: No ]
- New vertebral fractures [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Denosumab
denosumab
|
Drug: Denosumab
60mg subcutaneous injection 6 monthly for 2 doses
Other Name: Prolia
|
|
Active Comparator: bisphosphonates
continuation of bisphosphonates
|
Drug: bisphosphonates
continue present bisphosphonate treatment
Other Name: continuation of bisphosphonates in their usual dosages
|
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
- A daily dose of prednisolone (or equivalent) of more than 2.5mg within 3 months of study entry.
- Having received oral bisphosphonate treatment for at least 2 years.
- 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.
- Informed consent from patients.
Exclusion Criteria:
- Patients with previous use of denosumab or teriparatide.
- Premenopausal women who plan for pregnancy within 2 years of study entry or who do not agree for contraception within this 2-year period.
- Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
- Patients with unexplained hypocalcemia.
- Patients with serum creatinine level of >=200umol/L.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465568
Contacts
| Contact: Chi Chiu Mok, MD, FRCP | (852) 2468 5389 | ccmok2005@yahoo.com |
| Contact: Becky Fong, BSc | (852) 24868342 |
Locations
| China | |
| Tuen Mun Hospital | Recruiting |
| Hong Kong, China | |
| Contact: Chi Chiu Mok, MD, FRCP (852) 2468 5389 ccmok2005@yahoo.com | |
| Contact: Becky Fong, BSc (852) 24868342 | |
| Principal Investigator: Chi Chiu Mok, MD, FRCP | |
Sponsors and Collaborators
Tuen Mun Hospital
Investigators
| Principal Investigator: | Chi Chiu Mok, MD, FRCP | Tuen Mun Hospital |
More Information
No publications provided
| Responsible Party: | Chi Chiu Mok, Consultant, Tuen Mun Hospital |
| ClinicalTrials.gov Identifier: | NCT01465568 History of Changes |
| Other Study ID Numbers: | CREC/984/11 |
| Study First Received: | October 30, 2011 |
| Last Updated: | October 29, 2012 |
| Health Authority: | Hong Kong: Ethics Committee |
Keywords provided by Tuen Mun Hospital:
|
osteoporosis denosumab RANKL glucocorticoids |
Additional relevant MeSH terms:
|
Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Diphosphonates Glucocorticoids |
Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on June 18, 2013