Romosozumab in Women With Chronic SCI

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2024-06-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI

NCT05101018

Osteoporosis Spinal Cord Injuries

ACTIVE_NOT_RECRUITING PHASE4

Romosozumab Use to Build Skeletal Integrity

NCT05058976

Osteoporosis Osteoporosis, Postmenopausal Osteoporosis Fracture

ACTIVE_NOT_RECRUITING PHASE4

Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa

NCT04779216

Bone Density, Low Bone Loss Anorexia Nervosa +1 more

COMPLETED PHASE3

Romosozumab Effects on Bone Density, Muscle Mass, and Spine Surgery Outcomes

NCT06973109

Osteoporosis, Post-menopausal

NOT_YET_RECRUITING PHASE2

Romosozumab/Denosumab Study for Premenopausal IOP

NCT04800367

Premenopausal Idiopathic Osteoporosis

ACTIVE_NOT_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a single-site, singe-arm, open-label pilot study to evaluate safety and efficacy of a sequential drug treatment (12 months of romosozumab injections followed by 12 months with alendronate tablets) to treat bone loss in women with chronic SCI and OP.

During the first year, participants will receive monthly subcutaneous injections of romosozumab 210 mg. This drug works by increasing bone formation and is FDA-approved for treating OP in post-menopausal women at high risk of fracture or those who did not benefit from using other available OP treatments. During the second year, participants will take weekly oral alendronate 70 mg. Alendronate is FDA-approved for the treatment of osteopenia and the treatment of OP in post-menopausal women and men as well as for the prevention and treatment of glucocorticoid-induced OP. In this study, it will be used to help maintain any increases in bone mass gained from the year of treatment with romosozumab.

Twelve participants will receive the study drug treatment, take daily supplements (calcium and vitamin D), and return to the research site for study visits over the course of two years. Computerized tomography (CT) imaging, dual-energy X-ray absorptiometry (DXA) imaging, and serum bone markers will be collected at various time points.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis Bone Loss Osteopenia, Osteoporosis Spinal Cord Injuries Chronic Spinal Paralysis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Females with Chronic SCI

12-month treatment with monthly subcutaneous romosozumab injections (210 mg), followed by 12-month treatment with weekly oral alendronate tablets (70 mg)

Group Type EXPERIMENTAL

Romosozumab

Intervention Type DRUG

Year 1 study drug

Alendronate

Intervention Type DRUG

Year 2 study drug

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Romosozumab

Year 1 study drug

Intervention Type DRUG

Alendronate

Year 2 study drug

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Evenity Fosamax

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 delay emptying such as stricture or achalasia
* Known hypersensitivity to romosozumab or alendronate
* Increased risk of aspiration
* Osteonecrosis of the jaw (ONJ) or risk factor for ONJ, such as invasive dental procedures (e.g., tooth extraction, dental implants, oral surgery in the past 6 months), poor oral hygiene, periodontal and/or pre-existing dental disease, or planned invasive dental procedure over the next two years
* Heterotopic ossification of the knee region that interferes with CT analysis
* History of bone metastasis and skeletal malignancies
* History of alcoholism or drug abuse within the 2 years prior to study screening, which in the opinion of the investigator may affect subject's health and/or study commitment
* Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study
* Currently being prescribed anticonvulsants at a dose or frequency that is determined to interfere with bone metabolism as determined by the investigator
* Currently being prescribed glucocorticoids, other than inhaled glucocorticoids
* Current or use during past 5 years of any bone-active agents, including any FDA approved treatment (e.g., teriparatide, abaloparatide, denosumab, any bisphosphonate (oral or IV), raloxifene, bazedoxifene, hormone therapy (estrogen and estrogen/progestin) and calcitonin) as well as any strontium-containing compounds.
* Pregnant, planning to become pregnant, or lactating
* Any history of stroke or cardiovascular disease other than controlled hypertension
* Renal insufficiency (calculated creatinine clearance less than 35 ml/min)
* Any other neurological impairment that may impair ambulation or muscle function

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No