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Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01465568
First Posted: November 7, 2011
Last Update Posted: May 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chi Chiu Mok, Tuen Mun Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (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 Chi Chiu Mok, Tuen Mun Hospital:

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

Secondary Outcome 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 ]

Enrollment: 40
Study Start Date: December 2011
Study Completion Date: June 2014
Primary Completion Date: April 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01465568


Locations
China
Tuen Mun Hospital
Hong Kong, China
Sponsors and Collaborators
Tuen Mun Hospital
Investigators
Principal Investigator: Chi Chiu Mok, MD, FRCP Tuen Mun Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chi Chiu Mok, Consultant, Tuen Mun Hospital
ClinicalTrials.gov Identifier: NCT01465568     History of Changes
Other Study ID Numbers: CREC/984/11
First Submitted: October 30, 2011
First Posted: November 7, 2011
Last Update Posted: May 12, 2015
Last Verified: May 2015

Keywords provided by Chi Chiu Mok, Tuen Mun Hospital:
osteoporosis
denosumab
RANKL
glucocorticoids

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Glucocorticoids
Denosumab
Diphosphonates
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents


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