Osteoporosis, Post-menopausalPhase 2NCT06973109
Romosozumab Effects on Bone Density, Muscle Mass, and Spine Surgery Outcomes
A Phase 2 study testing Romosozumab and Alendronate (Fosamax) in people with Osteoporosis, Post-menopausal, run by University of Pittsburgh at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if romosozumab (Evenity) can improve bone and muscle health in postmenopausal women with osteoporosis who are undergoing lumbar spine surgery. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Osteoporosis, Post-menopausal
- What is being tested?
- Romosozumab and Alendronate (Fosamax)
- 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2026to Jun 2027
- Phase
- Phase 2
- 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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Post-menopausal female
- Diagnosed with osteoporosis (T-score ≤ -2.5).
- Scheduled for or planning posterior lumbar fusion for degenerative disease, at least 3 months in the future.
- Able to provide informed consent.
Who cannot join
- History of prior spinal surgery.
- Male sex.
- Current or prior use of osteoporosis medications within the past 3 years.
- Current use of anabolic agents other than romosozumab.
- Current use of androgen receptor (AR) modulators, such as testosterone replacement therapy or selective androgen receptor modulators (SARMs).
- Severe renal impairment (eGFR < 30 mL/min/1.73m²).
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- Known hypersensitivity to romosozumab, alendronate or zoledronic acid.
- Severe spinal deformity.
- Active malignancy or history of malignancy within the past 5 years.
- Any secondary cause of decreased BMD (e.g., hyperparathyroidism).
- Stroke or myocardial infarction in the past year.
- Planned fusion involving more than 4 levels.
- Uncorrected hypocalcemia and/or hypovitaminosis D
- Esophageal abnormalities
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center (UPMC) - Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Investigating the Efficacy of Romosozumab in Augmenting Bone Density and Muscle Mass to Enhance the Outcomes of Spine Surgery
The goal of this clinical trial is to learn if romosozumab (Evenity) can improve bone and muscle health in postmenopausal women with osteoporosis who are undergoing lumbar spine surgery. The main questions it aims to answer are:
- Does romosozumab improve bone strength and reduce the risk of complications during and after spine surgery?
- Does romosozumab increase muscle mass and help patients recover better from surgery?
Read more
Researchers will compare romosozumab (a monthly injection) to alendronate (a weekly pill), both approved treatments for osteoporosis, to see which is more effective in this surgical setting. Participants will:
- Be randomly assigned to receive romosozumab or alendronate
- Take standard vitamin supplements and receive a one-time dose of zoledronic acid near the end of the study
- Attend five study visits over about 12 months
- Undergo bone scans, muscle imaging, and complete health questionnaires before and after surgery
- Conditions
- Osteoporosis, Post-menopausal
- Being tested
- Romosozumab, Alendronate (Fosamax), Placebo Romosozumab, Placebo Alendronate
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RomosozumabDrug
Also called Evenity
Monthly subcutaneous injection (210 mg total dose) administered as two separate 105 mg injections, one per arm. Administered for 12 months to female patients ≥65 years undergoing spine surgery.
Alendronate (Fosamax)Drug
Also called Fosamax
Weekly oral dose (70 mg) administered for 12 months. Used as active comparator in control arm of study.
Placebo RomosozumabDrug
Monthly subcutaneous injections mimicking romosozumab in appearance and administration schedule. Administered to control group.
Placebo AlendronateDrug
Weekly oral placebo pill mimicking alendronate. Administered to treatment group.
| Study group | Role | What they receive |
|---|---|---|
| Romosozumab + Placebo Alendronate | Experimental | Participants will receive monthly subcutaneous injections of romosozumab (210 mg, one injection per arm) for 12 months, along with weekly oral placebo alendronate. Surgery will be performed 3 months after treatment initiation. DXA and CT scans will assess bone density and muscle mass. Functional outcomes will be evaluated via PROMs at baseline and follow-up. Receives: Drug: Romosozumab; Drug: Placebo Alendronate |
| Alendronate + Placebo Romosozumab | Active comparator | Participants will receive weekly oral doses of alendronate (70 mg) and monthly subcutaneous placebo injections mimicking romosozumab. Surgery will occur after 3 months of treatment. Bone density, muscle mass, and functional outcomes will be assessed similarly to the experimental arm. Receives: Drug: Alendronate (Fosamax); Drug: Placebo Romosozumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hounsfield Units (HU) at L1 Vertebra
This measure assesses changes in vertebral bone quality by measuring Hounsfield Units (HU) at the L1 vertebra via CT scans. HU values will be compared from baseline to post-treatment between the romosozumab and alendronate groups to evaluate bone density improvement.
Measured: Baseline, 3 months post-op, and 9 months post-op
Change in Vertebral Bone Mineral Density (BMD) at L1
This measure evaluates the efficacy of romosozumab in improving vertebral bone density in older adults undergoing spine surgery. BMD will be measured using DXA scans of the total hip and compared from baseline to post-treatment between the romosozumab and alendronate groups.
Measured: Baseline, 3 months post-op, and 9 months post-op
Secondary outcomes (3)
Change in L3 skeletal muscle index (L3 SMI)
This measure assesses the impact of romosozumab on muscle mass in patients undergoing spine surgery. L3SMI will be calculated from axial CT scans at the L3 vertebral level, normalized by patient height squared. Changes from baseline will be compared between treatment and control groups.
Measured: Baseline, 3 months post-op, and 9 months post-op
Change in Oswestry Disability Index (ODI)
This measure evaluates change in patient-reported disability related to lower back pain using the ODI. Scores range from 0 to 100, with higher scores indicating greater disability.
Measured: Baseline and 9 months post-op
Change in Visual Analog Scale (VAS) for Pain
This measure evaluates change in pain intensity using the VAS, which ranges from 0 (no pain) to 10 (worst possible pain).
Measured: Baseline and 9 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start20 Jun 2026 (estimated)
- Primary completion2 Mar 2027 (estimated)
- Study completionJun 2027 (estimated)
Why it stopped: Investigator left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, Post-menopausalStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen, The Greg Beckwith Foundation
- Responsible party
- Sponsor
- Investigators
- Nitin Agarwal, M.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973109
- Sponsor's protocol ID
- STUDY24090048
- Other IDs
- BECKW 12879, 2024YIRGA
- Status last verified
- Feb 2026
- First submitted
- 2 May 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) collected during the trial that underlies published results will be shared, including de-identified data on demographic variables, dual-energy X-ray absorptiometry (DXA) bone mineral density (BMD) measurements, Hounsfield unit (HU) values from CT scans, L3 skeletal muscle index, radiographic fusion outcomes, hardware complication data, and patient-reported outcomes (ODI and VAS scores). Data will be made available to other qualified researchers upon reasonable request following publication of primary results, contingent on IRB approval and data use agreements.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Efficacy of Romosozumab in Augmenting Bone Density and Muscle Mass to Enhance the Outcomes of Spine Surgery
- ClinicalTrials.gov ID
- NCT06973109
- Acronym / sponsor ID
- STUDY24090048
- Conditions
- Osteoporosis, Post-menopausal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Amgen, The Greg Beckwith Foundation
- Study start
- 20 Jun 2026 (estimated)
- Primary completion
- 2 Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 May 2025 (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.
The goal of this clinical trial is to learn if romosozumab (Evenity) can improve bone and muscle health in postmenopausal women with osteoporosis who are undergoing lumbar spine surgery. The main questions it aims to answer are:
- Does romosozumab improve bone strength and reduce the risk of complications during and after spine surgery?
- Does romosozumab increase muscle mass and help patients recover better from surgery?
Researchers will compare romosozumab (a monthly injection) to alendronate (a weekly pill), both approved treatments for osteoporosis, to see which is more effective in this surgical setting. Participants will:
- Be randomly assigned to receive romosozumab or alendronate
- Take standard vitamin supplements and receive a one-time dose of zoledronic acid near the end of the study
- Attend five study visits over about 12 months
- Undergo bone scans, muscle imaging, and complete health questionnaires before and after surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Romosozumab + Placebo Alendronate | Experimental | Drug: Romosozumab, Drug: Placebo AlendronateParticipants will receive monthly subcutaneous injections of romosozumab (210 mg, one injection per arm) for 12 months, along with weekly oral placebo alendronate. Surgery will be performed 3 months after treatment initiation. DXA and CT scans will assess bone density and muscle mass. Functional outcomes will be evaluated via PROMs at baseline and follow-up. |
| Alendronate + Placebo Romosozumab | Active comparator | Drug: Alendronate (Fosamax), Drug: Placebo RomosozumabParticipants will receive weekly oral doses of alendronate (70 mg) and monthly subcutaneous placebo injections mimicking romosozumab. Surgery will occur after 3 months of treatment. Bone density, muscle mass, and functional outcomes will be assessed similarly to the experimental arm. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Post-menopausal female
- Diagnosed with osteoporosis (T-score ≤ -2.5).
- Scheduled for or planning posterior lumbar fusion for degenerative disease, at least 3 months in the future.
- Able to provide informed consent.
Key exclusion criteria (14 listed)
- History of prior spinal surgery.
- Male sex.
- Current or prior use of osteoporosis medications within the past 3 years.
- Current use of anabolic agents other than romosozumab.
- Current use of androgen receptor (AR) modulators, such as testosterone replacement therapy or selective androgen receptor modulators (SARMs).
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 |
|---|---|---|
| RomosozumabAlso: EvenityMonthly subcutaneous injection (210 mg total dose) administered as two separate 105 mg injections, one per arm. Administered for 12 months to female patients ≥65 years undergoing spine surgery. | Drug | Romosozumab + Placebo Alendronate |
| Alendronate (Fosamax)Also: FosamaxWeekly oral dose (70 mg) administered for 12 months. Used as active comparator in control arm of study. | Drug | Alendronate + Placebo Romosozumab |
| Placebo RomosozumabMonthly subcutaneous injections mimicking romosozumab in appearance and administration schedule. Administered to control group. | Drug | Alendronate + Placebo Romosozumab |
| Placebo AlendronateWeekly oral placebo pill mimicking alendronate. Administered to treatment group. | Drug | Romosozumab + Placebo Alendronate |
Primary outcome
Change in Hounsfield Units (HU) at L1 Vertebra
Time frame: Baseline, 3 months post-op, and 9 months post-op
This measure assesses changes in vertebral bone quality by measuring Hounsfield Units (HU) at the L1 vertebra via CT scans. HU values will be compared from baseline to post-treatment between the romosozumab and alendronate groups to evaluate bone density improvement.
Change in Vertebral Bone Mineral Density (BMD) at L1
Time frame: Baseline, 3 months post-op, and 9 months post-op
This measure evaluates the efficacy of romosozumab in improving vertebral bone density in older adults undergoing spine surgery. BMD will be measured using DXA scans of the total hip and compared from baseline to post-treatment between the romosozumab and alendronate groups.
3 secondary outcomes
Change in L3 skeletal muscle index (L3 SMI)
Time frame: Baseline, 3 months post-op, and 9 months post-op
Change in Oswestry Disability Index (ODI)
Time frame: Baseline and 9 months post-op
Change in Visual Analog Scale (VAS) for Pain
Time frame: Baseline and 9 months post-op
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) collected during the trial that underlies published results will be shared, including de-identified data on demographic variables, dual-energy X-ray absorptiometry (DXA) bone mineral density (BMD) measurements, Hounsfield unit (HU) values from CT scans, L3 skeletal muscle index, radiographic fusion outcomes, hardware complication data, and patient-reported outcomes (ODI and VAS scores). Data will be made available to other qualified researchers upon reasonable request following publication of primary results, contingent on IRB approval and data use agreements.
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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.
Nitin Agarwal, M.D. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Romosozumab and Alendronate (Fosamax) in people with Osteoporosis, Post-menopausal, run by University of Pittsburgh 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 4 inclusion and 14 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: withdrawn, as of the sponsor's last update on 4 Jun 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Hounsfield Units (HU) at L1 Vertebra (time frame: Baseline, 3 months post-op, and 9 months post-op). 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?
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 4 Jun 2026.