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Romosozumab in Women With Chronic SCI
Phase 2 trial testing Romosozumab in Osteoporosis in 12 participants. Completed in 10 June 2024.
| Lead sponsor | Northwestern University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 1 March 2021 |
| Primary completion | 10 June 2024 |
| Estimated completion | 10 June 2024 |
| Sites | 1 location across United States |
Northwestern University
18 and older, female only, with Osteoporosis or Bone Loss. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change from baseline to the Month 12 visit in volumetric bone mineral content (vBMC) obtained via CT (three-dimensional) imaging of the knee.
| Group | Value | 95% CI |
|---|---|---|
| Females With Chronic SCI | -0.78 | -1.93 – -0.60 |
Change from baseline to the Month 12 visit in bone mineral density (BMD) obtained via DXA (two-dimensional) imaging of the total hip.
| Group | Value | 95% CI |
|---|---|---|
| Females With Chronic SCI | 0.023 | 0.016 – 0.033 |
| Group | Value | 95% CI |
|---|---|---|
| Females With Chronic SCI | 0.033 | 0.008 – 0.049 |
Change from baseline to the Month 12 visit in volumetric bone mineral content (vBMC) obtained via CT imaging of the hip.
| Group | Value | 95% CI |
|---|---|---|
| Females With Chronic SCI | 0.063 | -0.071 – 0.706 |
Change from baseline to the Month 12 visit in serum levels of CTX and P1NP.
| Group | Value | 95% CI |
|---|---|---|
| Females With Chronic SCI | -0.0093 | -0.048 – 0.025 |
| Group | Value | 95% CI |
|---|---|---|
| Females With Chronic SCI | -18.25 | -23.56 – -4.27 |
Time frame: 25 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Year 1: Romosozumab | Year 2: Alendronate |
|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | Year 1: Romosozumab | Year 2: Alendronate |
|---|---|---|---|
| Injection site reaction | General disorders | — | — |
| COVID-19 viral infection | Infections and infestations | — | — |
| Urinary tract infection (UTI) | Renal and urinary disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Bone Pain | Musculoskeletal and connective tissue disorders | — | — |
| Irregular menstruation | Reproductive system and breast disorders | — | — |
| Burn | Injury, poisoning and procedural complications | — | — |
| Spasticity | Nervous system disorders | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Laceration | Skin and subcutaneous tissue disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Upper respiratory infection (cold) | Respiratory, thoracic and mediastinal disorders | — | — |
| Neuralgia | Nervous system disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Skin infection | Skin and subcutaneous tissue disorders | — | — |
| Wound infection | Skin and subcutaneous tissue disorders | — | — |
| Anisocoria | Eye disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | — | — |
| Edema, ankle | General disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Onycholysis of toe | Skin and subcutaneous tissue disorders | — | — |
| Thromboembolic event (PE or DVT) | Vascular disorders | — | — |
| Surgical site bleeding | Surgical and medical procedures | — | — |
| Hypertension | Vascular disorders | — | — |
| Left knee injury | Injury, poisoning and procedural complications | — | — |
| Low phosphorous level | Blood and lymphatic system disorders | — | — |
| Blurred vision | Eye disorders | — | — |
| Adenomyosis | Reproductive system and breast disorders | — | — |
| Bruising | Injury, poisoning and procedural complications | — | — |
| Peripheral neuropathy | Nervous system disorders | — | — |
| Fatigue | General disorders | — | — |
| Bilateral ankle abrasions | Skin and subcutaneous tissue disorders | — | — |
| Palpitations | Cardiac disorders | — | — |
| Chills | General disorders | — | — |
| Right ankle sprain | Musculoskeletal and connective tissue disorders | — | — |
| Abscess to left buttock | Skin and subcutaneous tissue disorders | — | — |
| Gastroenteritis | Gastrointestinal disorders | — | — |
| Right hip subluxation | Musculoskeletal and connective tissue disorders | — | — |
Most-reported serious reactions: Pneumonia.
Data from ClinicalTrials.gov NCT04708886 adverse events section.
This two-year open-label pilot clinical trial will evaluate the efficacy and safety of romosozumab to treat bone loss in females with chronic spinal cord injury (SCI) and osteoporosis (OP). Participants will receive monthly injections of romosozumab during the first 12 months of the study. During the second year, participants will take oral alendronate tablets on a weekly basis.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing