OsteoporosisPhase 4NCT01465568
Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis
A Phase 4 study testing Denosumab and bisphosphonates in people with Osteoporosis, run by Tuen Mun Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Denosumab and bisphosphonates
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Dec 2011to Jun 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Osteoporosis
- Being tested
- Denosumab, bisphosphonates
- Keywords
- osteoporosis, denosumab, RANKL, glucocorticoids
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
Also called Prolia
60mg subcutaneous injection 6 monthly for 2 doses
bisphosphonatesDrug
Also called continuation of bisphosphonates in their usual dosages
continue present bisphosphonate treatment
| Study group | Role | What they receive |
|---|---|---|
| Denosumab | Active comparator | denosumab Receives: Drug: Denosumab |
| bisphosphonates | Active comparator | continuation of bisphosphonates Receives: Drug: bisphosphonates |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone mineral density (BMD) changes at the lumbar spine
Measured: baseline, 6 months and 12 months
Secondary outcomes (4)
BMD changes in the total hip and femoral neck
Measured: baseline, 6 months and 12 months
bone turnover markers
Measured: baseline, 6 months and 12 months
New vertebral fractures
Measured: 12 months
adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionApr 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuen Mun Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Chi Chiu Mok, Tuen Mun Hospital
- Investigators
- Chi Chiu Mok, MD, FRCP, Principal investigator, Tuen Mun Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465568
- Sponsor's protocol ID
- CREC/984/11
- Status last verified
- May 2015
- First submitted
- 30 Oct 2011
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25761434
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01465568
- Acronym / sponsor ID
- CREC/984/11
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, denosumab, RANKL, glucocorticoids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tuen Mun HospitalOther government
- Study start
- Dec 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 7 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denosumab | Active comparator | Drug: Denosumabdenosumab |
| bisphosphonates | Active comparator | Drug: bisphosphonatescontinuation of bisphosphonates |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DenosumabAlso: Prolia60mg subcutaneous injection 6 monthly for 2 doses | Drug | Denosumab |
| bisphosphonatesAlso: continuation of bisphosphonates in their usual dosagescontinue present bisphosphonate treatment | Drug | bisphosphonates |
Primary outcome
bone mineral density (BMD) changes at the lumbar spine
Time frame: baseline, 6 months and 12 months
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
- Derived from this study: PubMed 25761434Mok 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.
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi Chiu Mok, MD, FRCP principal investigator
Tuen Mun Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Denosumab and bisphosphonates in people with Osteoporosis, run by Tuen Mun Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone mineral density (BMD) changes at the lumbar spine (time frame: baseline, 6 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01465568, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.