Romosozumab in Women With Chronic SCI

September 8, 2025 updated by: Thomas J. Schnitzer, Northwestern University

Effects of Romosozumab on Bone Health in Women With Spinal Cord Injury and Osteoporosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Drug: Romosozumab
Year 1 study drug
Other Names:
  • Evenity
Drug: Alendronate
Year 2 study drug
Other Names:
  • Fosamax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Integral vBMC at the Knee (Distal Femur)
Time Frame: Baseline - 12 months
Change from baseline to the Month 12 visit in volumetric bone mineral content (vBMC) obtained via CT (three-dimensional) imaging of the knee.
Baseline - 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BMD at the Total Hip and Femoral Neck
Time Frame: Baseline - 12 months
Change from baseline to the Month 12 visit in bone mineral density (BMD) obtained via DXA (two-dimensional) imaging of the total hip.
Baseline - 12 months
Change in vBMC at the Hip
Time Frame: Baseline - 12 months
Change from baseline to the Month 12 visit in volumetric bone mineral content (vBMC) obtained via CT imaging of the hip.
Baseline - 12 months
Change in Serum Bone Biomarkers (CTX and P1NP)
Time Frame: Baseline - 12 months
Change from baseline to the Month 12 visit in serum levels of CTX and P1NP.
Baseline - 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BMC and BMD at regions of interest around the knee
Time Frame: Baseline - 12 months
Change from baseline to the Month 12 visit in BMC and BMD in the femur and tibia as collected via CT imaging of the index knee
Baseline - 12 months
Change in serum bone markers
Time Frame: Baseline - 12 months
Change from baseline to the Month 12 visit in serum biomarkers of bone turnover
Baseline - 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Amgen

Investigators

  • Principal Investigator: Thomas J Schnitzer, MD, PhD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

June 10, 2024

Study Completion (Actual)

June 10, 2024

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

January 12, 2021

First Posted (Actual)

January 14, 2021

Study Record Updates

Last Update Posted (Estimated)

September 24, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00212405
  • 20197268 (Other Identifier: Amgen Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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