OsteoporosisPhase 4NCT03005678
Denosumab Versus Bisphosphonates (Alendronate) in GIOP
A Phase 4 study testing Denosumab and Alendronate in people with Osteoporosis, run by Tuen Mun Hospital at 1 site in China.
Trial summary
A randomized controlled trial to compare for the efficacy and tolerability of denosumab and oral alendronate in the management of glucocorticoid induced osteoporosis 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 Alendronate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2017to 1 Feb 2020
- 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
- Adults (women or men) >18 years of age
- Receiving long-term prednisolone treatment for various medical illnesses, defined as a daily prednisolone dose of ≥2.5mg/day for ≥12 months).
- Informed consent from patients.
- Willing to comply with all study procedures
Who cannot join
- Patients with previous use of denosumab, teriparatide, intravenous bisphosphonates, strontium or other experimental anti-osteoporotic agents.
- Premenopausal women who plan for pregnancy within 18 months of study entry.
- 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 Versus Oral Bisphosphonate (Alendronate) for Osteoporosis in Long-term Glucocorticoid Users: an Open Randomized Controlled Trial
A randomized controlled trial to compare for the efficacy and tolerability of denosumab and oral alendronate in the management of glucocorticoid induced osteoporosis
Read the detailed description
Study design: an open-label randomized controlled trial Duration of study: 12 months
Treatment arms:
- Denosumab: a total of 2 doses in a period of 12 months
- Oral alendronate: weekly dose in a period of 12 months Target sample size: 220 patients (110 patients in each arm)
- Conditions
- Osteoporosis
- Being tested
- Denosumab, Alendronate
- Keywords
- glucocorticoids, steroids, osteoporosis
- 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
active treatment group
AlendronateDrug
Also called fosamax
comparator
| Study group | Role | What they receive |
|---|---|---|
| Denosumab | Active comparator | denosumab subcutaneous 60mg every 6 months Receives: Drug: Denosumab |
| Alendronate | Placebo comparator | alendronate 70mg orally every week Receives: Drug: Alendronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone mineral density at lumbar spine
BMD lumbar spine
Measured: month 12
Secondary outcomes (3)
bone mineral density at the hip
BMD hip
Measured: month 12
bone turnover markers
P1NP and osteocalcin
Measured: month 12
adverse events
adverse events
Measured: month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study start1 Apr 2017
- Primary completion1 Nov 2019
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 140 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
- CC Mok, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005678
- Sponsor's protocol ID
- CREC/16
- Status last verified
- Feb 2020
- First submitted
- 24 Dec 2016
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Denosumab Versus Oral Bisphosphonate (Alendronate) for Osteoporosis in Long-term Glucocorticoid Users: an Open Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03005678
- Acronym / sponsor ID
- CREC/16
- Conditions
- Osteoporosis
- Keywords
- glucocorticoids, steroids, osteoporosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Tuen Mun HospitalOther government
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 29 Dec 2016 (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.
A randomized controlled trial to compare for the efficacy and tolerability of denosumab and oral alendronate in the management of glucocorticoid induced osteoporosis
Detailed description
Study design: an open-label randomized controlled trial Duration of study: 12 months
Treatment arms:
- Denosumab: a total of 2 doses in a period of 12 months
- Oral alendronate: weekly dose in a period of 12 months Target sample size: 220 patients (110 patients in each arm)
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 subcutaneous 60mg every 6 months |
| Alendronate | Placebo comparator | Drug: Alendronatealendronate 70mg orally every week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (women or men) >18 years of age
- Receiving long-term prednisolone treatment for various medical illnesses, defined as a daily prednisolone dose of ≥2.5mg/day for ≥12 months).
- Informed consent from patients.
- Willing to comply with all study procedures
Key exclusion criteria (5 listed)
- Patients with previous use of denosumab, teriparatide, intravenous bisphosphonates, strontium or other experimental anti-osteoporotic agents.
- Premenopausal women who plan for pregnancy within 18 months of study entry.
- 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: proliaactive treatment group | Drug | Denosumab |
| AlendronateAlso: fosamaxcomparator | Drug | Alendronate |
Primary outcome
bone mineral density at lumbar spine
Time frame: month 12
BMD lumbar spine
3 secondary outcomes
bone mineral density at the hip
Time frame: month 12
bone turnover markers
Time frame: month 12
adverse events
Time frame: month 12
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 Feb 2020.
- Individual participant dataSharing planned: No
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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.
CC Mok principal investigator
Principal Investigator
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 Alendronate 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 4 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 Feb 2020. 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. Some participants in this study may receive a placebo. 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 at lumbar spine (time frame: month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2020.