OsteoporosisPhase 4RUBINCT05058976
Romosozumab Use to Build Skeletal Integrity
A Phase 4 study testing Romosozumab, Zoledronic acid and Calcium and Vitamin D in people with Osteoporosis and Osteoporosis, Postmenopausal, run by Susan L. Greenspan at 1 site in United States.
Trial summary
The purpose of this study is to find out if one year of romosozumab (Evenity®), a monthly injection given in the arm under the skin, prior to an infusion of zoledronic acid Reclast®, works to treat bone loss and prevent it from worsening in older women (ages 65 and older) who have osteoporosis and reside in long-term… Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Osteoporosis, Osteoporosis, Postmenopausal, Osteoporosis Fracture
- What is being tested?
- Romosozumab, Zoledronic acid and Calcium and Vitamin D
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2021to 31 Mar 2027
- 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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Elderly women 65 years and older will be considered if:
- They reside in an institution (nursing home or assisted living facility or senior care community);
- They have a) osteoporosis by axial bone density (spine, hip or forearm BMD T-score≤ -2.5 SD), b) a previous adult fragility fracture of the spine or hip or c) would be treated based on FRAX and the National Osteoporosis Foundation (NOF) treatment thresholds of a 10 year risk of 10% for a major osteoporotic fracture or ≥ 3% for hip fracture using femoral neck BMD.
- Willing and able to complete the informed consent process or provide consent by proxy.
Who cannot join
- Those with subacute illnesses who are not expected to survive or who will be discharged in less than 2 years.
- Those who have previously had an acute cardiovascular or cerebrovascular event within the preceding year. specifically, no recent history of coronary heart disease, heart failure, significant arrhythmia, stroke or Transient Ischemic Attack (TIA).
- Recent cardiovascular disease (CVD) symptoms (significant chest pain, congestive heart failure, shortness of breath, or palpitations or cerebrovascular symptoms such as numbness or weakness in the face, arm, legs, difficulty talking, changes in vision, loss of balance, headache, feeling light-headed or dizzy).
- Unstable angina.
- Those who are currently on therapy (including a bisphosphonate, denosumab, teriparatide, abaloparatide or romosozumab) or have been on a bisphosphonate for greater than 1 year during the previous 2 years.
- Those who are unable to take an intravenous bisphosphonate (zoledronic acid) due to renal insufficiency with eGFR < 35 ml/min.
Show all 11Show fewer
- Vitamin D levels <25 ng/mL.
- Participants will be allowed to continue on medications known to affect bone and mineral metabolism (e.g., glucocorticoids, anticonvulsants) because their use is common in this population.
- Those who have been treated in the past or present with osteoporosis agents, such as estrogen/progesterone or raloxifene will be allowed to participate and continue on these therapies if prescribed by their physician.
- Patients will be allowed to wear hip pads if prescribed by their physician.
- Non-ambulatory residents (those who cannot stand and pivot with assistance in order to transfer to the DXA table) will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Senior Communities
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Innovative Approach to Geriatric Osteoporosis
The purpose of this study is to find out if one year of romosozumab (Evenity®), a monthly injection given in the arm under the skin, prior to an infusion of zoledronic acid Reclast®, works to treat bone loss and prevent it from worsening in older women (ages 65 and older) who have osteoporosis and reside in long-term care (LTC) facilities.
Read the detailed description
Objective:
The long-term goal of this study is to improve health, well-being and quality of life in the frail Long-term Care (LTC) population by reducing fractures. The short-term goal is to demonstrate efficacy of the novel dual action Romosozumab (ROMO) to improve Bone Mineral Density (BMD) and skeletal integrity and its safety, a necessary (but not sufficient) precondition of a large fracture reduction trial. The investigators propose to conduct a 2-year, randomized, double-blind, calcium vitamin D controlled trial to test the efficacy and safety of the sclerostin inhibitor ROMO among a cohort of 200 underserved, institutionalized, frail women ≥65 years old. Bone measures will be collected in a mobile lab. The monthly subcutaneous therapy negates concerns regarding poor oral absorption or compliance. The use of annual Zoledronic Acid (ZOL) to follow ROMO, will prevent bone loss and insure the entire group will be provided with at least 1 year of therapy. The groups include: 1) ROMO →ZOL vs 2) placebo →ZOL.
Aim 1: Evaluate efficacy of bone building ROMO treatment prior to ZOL in improving bone mineral density. H1: Women on ROMO →ZOL will have greater hip and spine BMD increases after 2 years (H1.1-primary) and 1 year (H1.2), and at other locations (H1.3).
Aim 2: Examine improvements in 3D trabecular microstructure (TBS), markers of bone turnover and collect preliminary evidence for a fracture reduction trial. The investigators will measure vertebral trabecular bone score (TBS), a 3-D microarchitectural image and parameters of the spine, hip, and lateral spine H2: Women on ROMO →ZOL will have greater increases in TBS measures of spine, hip and lateral spine after one (H2.1) and two (H2.2) years; and improvement in bone turnover markers (CTx and P1NP; H2.3).
Aim 3: Determine characteristics associated with responders and non responders. The investigators will use multiple regression analyses and other data mining techniques to identify baseline characteristics of responders and non-responders. H3.1: Poor baseline functional/cognitive status/immobility will be associated with poor bone healthy outcomes. H3.2: Greater early changes in bone turnover markers will be associated with greater skeletal improvements.
- Being tested
- Romosozumab, Placebo, Zoledronic acid, Calcium and Vitamin D
- Keywords
- Bone loss, Nursing Home Patients, Long-term Care Patients, Osteoporotic Fractures
- Medical subject headings
- Osteoporosis, Osteoporosis, Postmenopausal, Osteoporotic Fractures, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RomosozumabDrug
Also called Evenity
Monthly dose: 210 mg subcutaneous injection
PlaceboDrug
Monthly saline injection
Zoledronic acidDrug
Also called Reclast
5 mg IV infusion at Month 12 Visit
Calcium and Vitamin DDietary supplement
Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
| Study group | Role | What they receive |
|---|---|---|
| Romosozumab, then Zoledronic Acid | Experimental | Monthly dose: 210 mg Romosozumab subcutaneous injections; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements); all participants will receive 5 mg Zoledronic Acid IV infusion at the Month 12 visit. Receives: Drug: Romosozumab; Drug: Zoledronic acid; Dietary Supplement: Calcium and Vitamin D |
| Placebo, then Zoledronic Acid | Placebo comparator | Monthly dose: placebo saline subcutaneous injections; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements); all participants will receive 5 mg Zoledronic Acid IV infusion at the Month 12 visit. Receives: Drug: Placebo; Drug: Zoledronic acid; Dietary Supplement: Calcium and Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density of the total hip
Bone Mineral Density (BMD) of the total hip at 24 months as assessed by dual-energy x-ray absorptiometry (DXA)
Measured: 24 months
Bone Mineral Density of the spine
Bone Mineral Density (BMD) of the spine at 24 months as assessed by dual-energy x-ray absorptiometry (DXA)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start15 Sep 2021
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susan L. Greenspan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Susan L. Greenspan, University of Pittsburgh
- Investigators
- Susan L Greenspan, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058976
- Sponsor's protocol ID
- STUDY20060028
- Other IDs
- 5R01AG066825-02
- Acronym
- RUBI
- Status last verified
- Feb 2026
- First submitted
- 17 Sep 2021
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data to be shared will include all IPD collected, with the exception of essential identifying information.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Approach to Geriatric Osteoporosis
- ClinicalTrials.gov ID
- NCT05058976
- Acronym / sponsor ID
- RUBI / STUDY20060028
- Keywords
- Bone loss, Nursing Home Patients, Long-term Care Patients, Osteoporotic Fractures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Susan L. GreenspanUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 28 Sep 2021 (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 purpose of this study is to find out if one year of romosozumab (Evenity®), a monthly injection given in the arm under the skin, prior to an infusion of zoledronic acid Reclast®, works to treat bone loss and prevent it from worsening in older women (ages 65 and older) who have osteoporosis and reside in long-term care (LTC) facilities.
Detailed description
Objective:
The long-term goal of this study is to improve health, well-being and quality of life in the frail Long-term Care (LTC) population by reducing fractures. The short-term goal is to demonstrate efficacy of the novel dual action Romosozumab (ROMO) to improve Bone Mineral Density (BMD) and skeletal integrity and its safety, a necessary (but not sufficient) precondition of a large fracture reduction trial. The investigators propose to conduct a 2-year, randomized, double-blind, calcium vitamin D controlled trial to test the efficacy and safety of the sclerostin inhibitor ROMO among a cohort of 200 underserved, institutionalized, frail women ≥65 years old. Bone measures will be collected in a mobile lab. The monthly subcutaneous therapy negates concerns regarding poor oral absorption or compliance. The use of annual Zoledronic Acid (ZOL) to follow ROMO, will prevent bone loss and insure the entire group will be provided with at least 1 year of therapy. The groups include: 1) ROMO →ZOL vs 2) placebo →ZOL.
Aim 1: Evaluate efficacy of bone building ROMO treatment prior to ZOL in improving bone mineral density. H1: Women on ROMO →ZOL will have greater hip and spine BMD increases after 2 years (H1.1-primary) and 1 year (H1.2), and at other locations (H1.3).
Aim 2: Examine improvements in 3D trabecular microstructure (TBS), markers of bone turnover and collect preliminary evidence for a fracture reduction trial. The investigators will measure vertebral trabecular bone score (TBS), a 3-D microarchitectural image and parameters of the spine, hip, and lateral spine H2: Women on ROMO →ZOL will have greater increases in TBS measures of spine, hip and lateral spine after one (H2.1) and two (H2.2) years; and improvement in bone turnover markers (CTx and P1NP; H2.3).
Aim 3: Determine characteristics associated with responders and non responders. The investigators will use multiple regression analyses and other data mining techniques to identify baseline characteristics of responders and non-responders. H3.1: Poor baseline functional/cognitive status/immobility will be associated with poor bone healthy outcomes. H3.2: Greater early changes in bone turnover markers will be associated with greater skeletal improvements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Romosozumab, then Zoledronic Acid | Experimental | Drug: Romosozumab, Drug: Zoledronic acid, Dietary Supplement: Calcium and Vitamin DMonthly dose: 210 mg Romosozumab subcutaneous injections; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements); all participants will receive 5 mg Zoledronic Acid IV infusion at the Month 12 visit. |
| Placebo, then Zoledronic Acid | Placebo comparator | Drug: Placebo, Drug: Zoledronic acid, Dietary Supplement: Calcium and Vitamin DMonthly dose: placebo saline subcutaneous injections; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements); all participants will receive 5 mg Zoledronic Acid IV infusion at the Month 12 visit. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- They reside in an institution (nursing home or assisted living facility or senior care community);
- They have a) osteoporosis by axial bone density (spine, hip or forearm BMD T-score≤ -2.5 SD), b) a previous adult fragility fracture of the spine or hip or c) would be treated based on FRAX and the National Osteoporosis Foundation (NOF) treatment thresholds of a 10 year risk of 10% for a major osteoporotic fracture or ≥ 3% for hip fracture using femoral neck BMD.
- Willing and able to complete the informed consent process or provide consent by proxy.
Key exclusion criteria (11 listed)
- Those with subacute illnesses who are not expected to survive or who will be discharged in less than 2 years.
- Those who have previously had an acute cardiovascular or cerebrovascular event within the preceding year. specifically, no recent history of coronary heart disease, heart failure, significant arrhythmia, stroke or Transient Ischemic Attack (TIA).
- Recent cardiovascular disease (CVD) symptoms (significant chest pain, congestive heart failure, shortness of breath, or palpitations or cerebrovascular symptoms such as numbness or weakness in the face, arm, legs, difficulty talking, changes in vision, loss of balance, headache, feeling light-headed or dizzy).
- Unstable angina.
- Those who are currently on therapy (including a bisphosphonate, denosumab, teriparatide, abaloparatide or romosozumab) or have been on a bisphosphonate for greater than 1 year during the previous 2 years.
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 dose: 210 mg subcutaneous injection | Drug | Romosozumab, then Zoledronic Acid |
| PlaceboMonthly saline injection | Drug | Placebo, then Zoledronic Acid |
| Zoledronic acidAlso: Reclast5 mg IV infusion at Month 12 Visit | Drug | Placebo, then Zoledronic Acid, Romosozumab, then Zoledronic Acid |
| Calcium and Vitamin DVitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement) | Dietary supplement | Placebo, then Zoledronic Acid, Romosozumab, then Zoledronic Acid |
Primary outcome
Bone Mineral Density of the total hip
Time frame: 24 months
Bone Mineral Density (BMD) of the total hip at 24 months as assessed by dual-energy x-ray absorptiometry (DXA)
Bone Mineral Density of the spine
Time frame: 24 months
Bone Mineral Density (BMD) of the spine at 24 months as assessed by dual-energy x-ray absorptiometry (DXA)
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 17 Feb 2026.
- Individual participant dataSharing planned: Yes. Data to be shared will include all IPD collected, with the exception of essential identifying information.
Related trials for Osteoporosis
Enrolling by invitationPhase 3
Quanduzhong Capsules for Primary Osteoporosis
Primary Osteoporosis
RecruitingObservational study
A Natural History Study of Bone and Mineral Disorders
Tumor Induced Osteomalcia, Osteomalacia
RecruitingObservational study
A Study Evaluating the Performance of Using AI Software and Chest X-rays to Screen for Osteoporosis as Compared to Standard DXA Scans in Patients 50 Years and Older
Osteoporosis, Osteopenia
RecruitingObservational study
Bone Health in Adults With Duchenne Muscular Dystrophy: A Survey on Osteoporosis, Fractures and Treatment.
Duchenne Muscular Dystrophy (DMD)
RecruitingObservational study
REMS vs DXA for Osteoporosis Diagnosis and Fracture Risk Prediction
Osteoporosis Diagnosis, Bone Health
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.
Susan L Greenspan, MD 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 4 study testing Romosozumab, Zoledronic acid and Calcium and Vitamin D in people with Osteoporosis and Osteoporosis, Postmenopausal, run by Susan L. Greenspan 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 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 17 Feb 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. 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?
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?
Bone Mineral Density of the total hip (time frame: 24 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?
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 17 Feb 2026.