Osteoporosis, PostmenopausalPhase 4CATNCT06558188
Combined Anabolic Therapy
A Phase 4 study testing Romosozumab and Teriparatide in people with Osteoporosis, Postmenopausal and Osteoporosis, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
In this research study the study investigators want to learn more about the effect of two different FDA-approved medication regimens in the treatment of postmenopausal osteoporosis. 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?
- Romosozumab and Teriparatide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2025to 19 Nov 2027
- Phase
- Phase 4
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
Who cannot join
- no significant previous use of bone health modifying treatments
- 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
- anemia (hematocrit <32%)
Show all 9Show fewer
- history of malignancy (except non-melanoma skin carcinoma)
- excessive alcohol use or substance abuse
- known contraindications to romosozumab or teriparatide
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Aparna Patnaik, BA, 617-726-6129, apatnaik1@mgh.harvard.edu
About this study
Official title: Combined Anabolic Therapy Study
In this research study the study investigators want to learn more about the effect of two different FDA-approved medication regimens in the treatment of postmenopausal osteoporosis.
- Conditions
- Osteoporosis, Postmenopausal, Osteoporosis
- Being tested
- Romosozumab, Teriparatide
- 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.
RomosozumabDrug
Also called Evenity
romosozumab 210 milligrams monthly
TeriparatideDrug
Also called Forteo
teriparatide 20 micrograms daily
| Study group | Role | What they receive |
|---|---|---|
| Romosozumab | Active comparator | romosozumab Receives: Drug: Romosozumab |
| Romosozumab and Teriparatide | Active comparator | romosozumab and teriparatide Receives: Drug: Romosozumab; Drug: Teriparatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar spine areal bone mineral density
Change in lumbar spine bone density between month 0 and month 12
Measured: Month 0 to 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start3 Feb 2025
- Primary completion2 Nov 2027 (estimated)
- Study completion19 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Benjamin Leder, MD, Massachusetts General Hospital
- Investigators
- Benjamin Leder, MD, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558188
- Sponsor's protocol ID
- 2024P002279
- Other IDs
- 1R21AR083567-01A1
- Acronym
- CAT
- Status last verified
- Oct 2026
- First submitted
- 14 Aug 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided