Romosozumab in Women With Chronic SCI (NCT04708886) | Clinical Trial Compass
CompletedPhase 2
Romosozumab in Women With Chronic SCI
United States12 participantsStarted 2021-03-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years
* Female sex
* SCI 6 or more months prior to enrollment
* Non-ambulatory status (Walking Index for Spinal Cord Injury II score of 3 or less)
* Osteoporosis by DXA defined as a t-score of -2.5 at any skeletal site (lumbar spine, total hip, or femoral neck) or a t-score of -2.0 plus a history of a fragility fracture
* Good general health, as determined by the study investigator
* Able to understand and agree to informed consent in English
* Able and willing to complete all the study visits
* Females of childbearing potential must be willing and able to use an effective method of contraception or practice abstinence throughout the course of the study and up to 90 days after the last use of study drug.
* Vitamin D 25-hydroxy levels ≥ 20 ng/ml (subjects may be repleted and retested prior to baseline)
* Normal serum calcium levels (based on current local laboratory normal range)
* No known endocrinopathies (diabetes type 1 or 2, treated thyroid conditions can be included)
* Normal serum thyroid stimulating hormone and/or T4 levels (based on current local laboratory normal ranges)
* Able to take oral medication sitting upright for at least 30 minutes
Exclusion criteria:
* Have Paget's disease of the bone
* Have abnormal laboratory values that in the judgement of the investigator would put the participant at increased risk of treatment
* Any active gastrointestinal condition that results in malabsorption
* Abnormalities of the esophagus which de…
What they're measuring
1
Change in Integral vBMC at the Knee (Distal Femur)