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Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Chi Chiu Mok, Tuen Mun Hospital
ClinicalTrials.gov Identifier:
NCT01465568
First received: October 30, 2011
Last updated: March 3, 2014
Last verified: March 2014
  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: June 2014
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: March 3, 2014
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Tuen Mun Hospital:
osteoporosis
denosumab
RANKL
glucocorticoids

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

ClinicalTrials.gov processed this record on November 25, 2014