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Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis

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. Identifier: NCT01465568
Recruitment Status : Completed
First Posted : November 6, 2011
Last Update Posted : May 12, 2015
Information provided by (Responsible Party):
Chi Chiu Mok, Tuen Mun Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Denosumab Drug: bisphosphonates Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Study Start Date : December 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Denosumab

Arm Intervention/treatment
Active Comparator: 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

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

Secondary Outcome Measures :
  1. BMD changes in the total hip and femoral neck [ Time Frame: baseline, 6 months and 12 months ]
  2. bone turnover markers [ Time Frame: baseline, 6 months and 12 months ]
  3. New vertebral fractures [ Time Frame: 12 months ]
  4. adverse events [ Time Frame: 12 months ]

Information from the National Library of Medicine

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

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.

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 identifier (NCT number): NCT01465568

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Chi Chiu Mok, Consultant, Tuen Mun Hospital Identifier: NCT01465568    
Other Study ID Numbers: CREC/984/11
First Posted: November 6, 2011    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015
Keywords provided by Chi Chiu Mok, Tuen Mun Hospital:
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists