Phase 4
Completed N=201
Preventing Osteoporosis Using Denosumab
Osteoporosis, Postmenopausal · Osteoporosis · Osteoporotic fractures
Source: ClinicalTrials.gov NCT02753283 ↗
Enrolled (actual)
201
Serious AEs
41.3%
Results posted
Sep 2024
Primary outcomePrimary: Bone Density of the Total Hip — 4.62; -0.19; 3.74; 0.48 Percent change — p=.007
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this research study is to find out if denosumab (Prolia®), an injection given in the arm under the skin every 6 months, works to treat bone loss and prevent it from worsening in older men and women (ages 65 and older) who have osteoporosis and reside in long-term care (LTC) facilities.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bone Density of the Total Hip |
4.62; -0.19; 3.74; 0.48 | .007 sig |
| PRIMARY Bone Density of the Spine |
7.41; 2.15; 7.91; 1.12 | .014 sig |
| SECONDARY Distal Radius BMD |
2.030; -.376; 2.386; -1.115 | .060 |
| SECONDARY Femoral Neck BMD |
3.212; .185; 2.932; -.958 | .112 |
| SECONDARY TBS |
3.007; 1.099; 2.370; 3.318 | .904 |
Eligibility Criteria
Inclusion Criteria
Ambulatory male and female residents with osteoporosis or low bone mass (at risk for fracture) ages 65 and older will be considered if:
- Reside in long-term care institution (nursing home or assisted living facility); and
- HaveOsteoporosis: (1) by bone density [spine, hip or forearm Bone Mineral Density (BMD) T-score ≤ -2.5]; (2) A previous adult fragility fracture of the spine or hip; or (3) Would be treated based on FRAX® and the National Osteoporosis Foundation (NOF) treatment thresholds of a 10 year risk of ≥ 20% for a major fracture or ≥ 3% for hip fracture suing femoral neck BMD.
Exclusion Criteria
- Institutionalized residents with subacute illnesses who are not expected to survive or who will be discharged in 1year during the previous 2 years because some bisphosphonates are long acting.
- Those with a history of hypocalcemia or contraindication for treatment. We will screen for these conditions by detailed history, chart review, and baseline laboratory analyses.
- Those with vitamin D levels < 25ng/mL will be treated with vitamin D 50,000 IU/wk for 8 weeks; they will be enrolled if the follow-up vitamin D level is 25 ng/mL or more (if after 2 rounds of vitamin D repletion their vitamin D level is not at least 25 ng/mL, they will not be eligible to be randomized into the study).
- Those on dialysis or with stage 5 chronic kidney disease (eGFR<15ml/min) will be excluded at screening.
- Those requiring tooth extraction or oral surgery will not be enrolled until cleared by a dentist.
- Patients will be allowed to continue on glucocorticoids and anticonvulsants because their use is common in this population.
- Those on glucocorticoids and anticonvulsants will be allowed to continue in the study because their use is common in this population.
- Those on hormone replacement therapy (HRT), raloxifene, or prescribed protective hip pads by their Primary Care Physician (PCP) will be allowed to participate and continue on these therapies.
- We will suggest that participants stop long-term calcitonin as it has been discontinued in Europe due to cancer concerns.
Data sourced from ClinicalTrials.gov (NCT02753283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.