Romosozumab in Women With Chronic SCI

NCT04708886 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: STU0021240520197268
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Spinal Cord Injury; Osteoporosis; Romosozumab (Evenity); Alendronate (Fosamax); Bone Diseases; Metabolic Bone Diseases; Anabolic Treatment; Bisphosphonate; Bone Density; Spinal Cord Diseases; Romosozumab; Alendronate; Physiological Effects of Drugs

Outcome Measures

Primary Outcomes (1)

• Change in Integral vBMC at the Knee (Distal Femur)

  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 Outcomes (3)

• Change in BMD at the Total Hip and Femoral Neck

  Baseline - 12 months

• Change in vBMC at the Hip

  Baseline - 12 months

• Change in Serum Bone Biomarkers (CTX and P1NP)

  Baseline - 12 months

Study Arms (1)

Females with Chronic SCI

EXPERIMENTAL

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

Drug: Romosozumab; Drug: Alendronate

Interventions

Romosozumab DRUG

Year 1 study drug

Also known as: Evenity

Females with Chronic SCI

Alendronate DRUG

Year 2 study drug

Also known as: Fosamax

Females with Chronic SCI

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Amgen: collaborator

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (3)

• Cosman F, Crittenden DB, Adachi JD, Binkley N, Czerwinski E, Ferrari S, Hofbauer LC, Lau E, Lewiecki EM, Miyauchi A, Zerbini CA, Milmont CE, Chen L, Maddox J, Meisner PD, Libanati C, Grauer A. Romosozumab Treatment in Postmenopausal Women with Osteoporosis. N Engl J Med. 2016 Oct 20;375(16):1532-1543. doi: 10.1056/NEJMoa1607948. Epub 2016 Sep 18.

  PMID: 27641143 BACKGROUND

• Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, Maddox J, Fan M, Meisner PD, Grauer A. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017 Oct 12;377(15):1417-1427. doi: 10.1056/NEJMoa1708322. Epub 2017 Sep 11.

  PMID: 28892457 BACKGROUND

• Keaveny TM, Crittenden DB, Bolognese MA, Genant HK, Engelke K, Oliveri B, Brown JP, Langdahl BL, Yan C, Grauer A, Libanati C. Greater Gains in Spine and Hip Strength for Romosozumab Compared With Teriparatide in Postmenopausal Women With Low Bone Mass. J Bone Miner Res. 2017 Sep;32(9):1956-1962. doi: 10.1002/jbmr.3176. Epub 2017 Jun 26.

  PMID: 28543940 BACKGROUND

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic; Spinal Cord Injuries; Bone Diseases; Spinal Cord Diseases

Interventions

romosozumab; Alendronate

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Results Point of Contact

• Title: Thomas Schnitzer
• Organization: Northwestern University Feinberg School of Medicine

tjs@northwestern.edu

3125032315

Study Officials

• Thomas J Schnitzer, MD, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 14, 2021
• Study Start: March 1, 2021
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: September 24, 2025
• Results First Posted: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)