NCT05058976Active, not recruitingPhase 4
Romosozumab Use to Build Skeletal Integrity
Innovative Approach to Geriatric Osteoporosis
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 184 (actual)
- First submitted
- 17 Sept 2021
- Start date
- 15 Sept 2021
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Susan L. Greenspan
- Diseases
- Osteoporosis
- NCT number
- NCT05058976
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 184
- From 15 Sept 2021 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
- 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.
- 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.
Other illness
- Those with subacute illnesses who are not expected to survive or who will be discharged in less than 2 years.
- 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.
Lab values
- Those who are unable to take an intravenous bisphosphonate (zoledronic acid) due to renal insufficiency with eGFR \< 35 ml/min.
Other
- Vitamin D levels \<25 ng/mL.
- 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.
Who the study is looking for
- 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.
Age in the registry: 65 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UPMC Senior Communities Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.