Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis

May 11, 2015 updated by: Chi Chiu Mok, Tuen Mun Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Tuen Mun Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Denosumab
denosumab
Drug: Denosumab
60mg subcutaneous injection 6 monthly for 2 doses
Other Names:
  • Prolia
ACTIVE_COMPARATOR: bisphosphonates
continuation of bisphosphonates
Drug: bisphosphonates
continue present bisphosphonate treatment
Other Names:
  • continuation of bisphosphonates in their usual dosages

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
bone mineral density (BMD) changes at the lumbar spine
Time Frame: baseline, 6 months and 12 months
baseline, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse events
Time Frame: 12 months
12 months
BMD changes in the total hip and femoral neck
Time Frame: baseline, 6 months and 12 months
baseline, 6 months and 12 months
bone turnover markers
Time Frame: baseline, 6 months and 12 months
baseline, 6 months and 12 months
New vertebral fractures
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tuen Mun Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

October 30, 2011

First Submitted That Met QC Criteria

November 4, 2011

First Posted (ESTIMATE)

November 6, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2015

Last Update Submitted That Met QC Criteria

May 11, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC/984/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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