Osteoporosis, PostmenopausalPhase 4NCT03623633
Comparative Antiresorptive Efficacy Discontinuation of Denosumab
A Phase 4 study testing denosumab, alendronate and raloxifene in people with Osteoporosis, Postmenopausal and Osteoporosis, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Osteoporosis remains a significant healthcare burden for the United States. Current FDA-approved osteoporosis treatments include teriparatide, abaloparatide, bisphosphonates, denosumab, and raloxifene. Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Postmenopausal, Osteoporosis
- What is being tested?
- denosumab, alendronate and raloxifene
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2018to 1 Aug 2023
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 45 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women aged 45+
- postmenopausal
- osteoporotic with high risk of fracture as per National Osteoporosis Foundation guidelines
Who cannot join
- no significant previous use of bone health modifying treatments
- hip fracture within one year of enrollment
- known congenital or acquired bone disease other than osteoporosis
- significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease
- abnormal calcium or parathyroid hormone level
- serum vitamin D <20 ng/dL
Show all 11Show fewer
- anemia (hematocrit <32%)
- history of malignancy (except non-melanoma skin carcinoma)
- excessive alcohol use or substance abuse
- extensive dental work involving extraction or dental implant within the past 6 months or in the upcoming 12 months
- known contraindications to denosumab, alendronate, or raloxifene
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Comparative Antiresorptive Efficacy of Alendronate or Raloxifene Following Discontinuation of Denosumab
Osteoporosis remains a significant healthcare burden for the United States. Current FDA-approved osteoporosis treatments include teriparatide, abaloparatide, bisphosphonates, denosumab, and raloxifene.
Denosumab is a fully human monoclonal antibody that specifically binds to receptor activator of nuclear factor kappa-B ligand (RANKL). Denosumab potently suppresses osteoclastic activity but bone turnover rapidly normalizes and bone turnover marker levels can rebound above baseline levels after the drug is discontinued.
This study will help us determine the optimal duration and relative efficacy of two oral antiresorptive medications that are FDA-approved for treatment of postmenopausal osteoporosis (alendronate and raloxifene) in preventing the rebound increase in bone turnover that occurs after denosumab discontinuation.
- Conditions
- Osteoporosis, Postmenopausal, Osteoporosis
- Being tested
- denosumab, alendronate, raloxifene
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
denosumabDrug
Also called Prolia
denosumab 60 milligrams subcutaneously every 6 months
alendronateDrug
Also called Fosamax
alendronate 70 milligrams weekly
raloxifeneDrug
Also called Evista
raloxifene 60 milligrams daily
| Study group | Role | What they receive |
|---|---|---|
| Denosumab and Raloxifene | Active comparator | denosumab and raloxifene Receives: Drug: denosumab; Drug: raloxifene |
| Denosumab and Alendronate | Active comparator | denosumab and alendronate Receives: Drug: denosumab; Drug: alendronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum c-telopeptide (CTX)
Change in serum CTX between month 12 and month 18
Measured: Month 12 to 18 months
Bone mineral density (BMD)
Change in PA spine BMD between month 24 and month 36
Measured: Month 24 to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start30 Nov 2018
- Primary completion1 Feb 2023
- Study completion1 Aug 2023 (estimated)
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 Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joy Tsai, Massachusetts General Hospital
- Investigators
- Joy Tsai, MD, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623633
- Sponsor's protocol ID
- 2018P001612
- Status last verified
- Jun 2023
- First submitted
- 6 Aug 2018
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tsai JN, Jordan M, Lee H, Leder BZ. One versus 2 years of alendronate following denosumab: the CARD extension. Osteoporos Int. 2024 Dec;35(12):2225-2230. doi: 10.1007/s00198-024-07213-2. Epub 2024 Aug 7.
PubMed 39112628
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Antiresorptive Efficacy of Alendronate or Raloxifene Following Discontinuation of Denosumab
- ClinicalTrials.gov ID
- NCT03623633
- Acronym / sponsor ID
- 2018P001612
- Conditions
- Osteoporosis, Postmenopausal, Osteoporosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 9 Aug 2018 (actual)
- 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.
Osteoporosis remains a significant healthcare burden for the United States. Current FDA-approved osteoporosis treatments include teriparatide, abaloparatide, bisphosphonates, denosumab, and raloxifene.
Denosumab is a fully human monoclonal antibody that specifically binds to receptor activator of nuclear factor kappa-B ligand (RANKL). Denosumab potently suppresses osteoclastic activity but bone turnover rapidly normalizes and bone turnover marker levels can rebound above baseline levels after the drug is discontinued.
This study will help us determine the optimal duration and relative efficacy of two oral antiresorptive medications that are FDA-approved for treatment of postmenopausal osteoporosis (alendronate and raloxifene) in preventing the rebound increase in bone turnover that occurs after denosumab discontinuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denosumab and Raloxifene | Active comparator | Drug: denosumab, Drug: raloxifenedenosumab and raloxifene |
| Denosumab and Alendronate | Active comparator | Drug: denosumab, Drug: alendronatedenosumab and alendronate |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women aged 45+
- postmenopausal
- osteoporotic with high risk of fracture as per National Osteoporosis Foundation guidelines
Key exclusion criteria (11 listed)
- no significant previous use of bone health modifying treatments
- hip fracture within one year of enrollment
- known congenital or acquired bone disease other than osteoporosis
- significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease
- abnormal calcium or parathyroid hormone level
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: Proliadenosumab 60 milligrams subcutaneously every 6 months | Drug | Denosumab and Alendronate, Denosumab and Raloxifene |
| alendronateAlso: Fosamaxalendronate 70 milligrams weekly | Drug | Denosumab and Alendronate |
| raloxifeneAlso: Evistaraloxifene 60 milligrams daily | Drug | Denosumab and Raloxifene |
Primary outcome
Serum c-telopeptide (CTX)
Time frame: Month 12 to 18 months
Change in serum CTX between month 12 and month 18
Bone mineral density (BMD)
Time frame: Month 24 to 36 months
Change in PA spine BMD between month 24 and month 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Derived from this study: PubMed 39112628Tsai JN, Jordan M, Lee H, Leder BZ. One versus 2 years of alendronate following denosumab: the CARD extension. Osteoporos Int. 2024 Dec;35(12):2225-2230. doi: 10.1007/s00198-024-07213-2. Epub 2024 Aug 7.
- Individual participant dataSharing planned: Undecided
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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.
Joy Tsai, MD principal investigator
MGH
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, alendronate and raloxifene in people with Osteoporosis, Postmenopausal and Osteoporosis, run by Massachusetts General Hospital at 1 site in United States.
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 3 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 7 Jun 2023. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Serum c-telopeptide (CTX) (time frame: Month 12 to 18 months). The study lists 2 primary outcomes in all. 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 NCT03623633, 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 7 Jun 2023.