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Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis

Primary Purpose

Osteoporosis

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Denosumab

bisphosphonates

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring osteoporosis, denosumab, RANKL, glucocorticoids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Tuen Mun Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Denosumab

bisphosphonates

Arm Description

denosumab

continuation of bisphosphonates

Outcomes

Primary Outcome Measures

bone mineral density (BMD) changes at the lumbar spine

Secondary Outcome Measures

BMD changes in the total hip and femoral neck

bone turnover markers

New vertebral fractures

adverse events

Full Information

NCT ID

NCT01465568

First Posted

October 30, 2011

Last Updated

May 11, 2015

Sponsor

Tuen Mun Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01465568

Brief Title

Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tuen Mun Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

Keywords

osteoporosis, denosumab, RANKL, glucocorticoids

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Denosumab

Arm Type

Active Comparator

Arm Description

denosumab

Arm Title

bisphosphonates

Arm Type

Active Comparator

Arm Description

continuation of bisphosphonates

Intervention Type

Drug

Intervention Name(s)

Denosumab

Other Intervention Name(s)

Prolia

Intervention Description

60mg subcutaneous injection 6 monthly for 2 doses

Intervention Type

Drug

Intervention Name(s)

bisphosphonates

Other Intervention Name(s)

continuation of bisphosphonates in their usual dosages

Intervention Description

continue present bisphosphonate treatment

Primary Outcome Measure Information:

Title

bone mineral density (BMD) changes at the lumbar spine

Time Frame

baseline, 6 months and 12 months

Secondary Outcome Measure Information:

Title

BMD changes in the total hip and femoral neck

Time Frame

baseline, 6 months and 12 months

Title

bone turnover markers

Time Frame

baseline, 6 months and 12 months

Title

New vertebral fractures

Time Frame

12 months

Title

adverse events

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chi Chiu Mok, MD, FRCP

Organizational Affiliation

Tuen Mun Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tuen Mun Hospital

City

Hong Kong

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

25761434

Citation

Mok CC, Ho LY, Ma KM. Switching of oral bisphosphonates to denosumab in chronic glucocorticoid users: a 12-month randomized controlled trial. Bone. 2015 Jun;75:222-8. doi: 10.1016/j.bone.2015.03.002. Epub 2015 Mar 8.

Results Reference

derived

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Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis

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