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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05101018
• Other study ID #: BAU-19-60
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: November 1, 2021
• Est. completion date: November 1, 2027

Study information

• Verified date: February 2024
• Source: James J. Peters Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the proposed work is to determine whether administration for 12 months of romosozumab followed by 12 months of denosumab will maintain bone mass at the knee in subjects with subacute SCI compared to 24 months of denosumab administration alone.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: November 1, 2027
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Traumatic motor-complete or incomplete SCI C4-L2 (AIS grade A-C);

2. Duration of SCI less than 6 months;

3. Males and females (premenopausal) between the ages of 18 and 55 years old; and a safe range of BMD right above the knee as determined by study staff review;

Exclusion Criteria:

1. Active and/or history of coronary heart disease or stroke;

2. Bone cancer;

3. Long-bone fracture of the leg within the past year;

4. History of prior bone disease (for example, Paget's hyperparathyroidism, osteoporosis, etc.);

5. Postmenopausal women;

6. Men with known low functioning tests before SCI;

7. Drugs geared toward increasing BMD longer than a six month duration after SCI;

8. As determined by study staff review of my medication history of glucocorticoid administration longer than three months duration within the last year

9. Abnormalities of my endocrine glands such as hyperthyroidism, Cushing's disease or syndrome, etc.;

10. Severe underlying chronic disease (for example chronic obstructive pulmonary disease (COPD), end-stage heart disease, chronic renal failure);

11. Heterotopic ossification (HO) of the distal femur (the knee end of the thigh bone). HO is a condition where bone tissue forms outside of the skeleton. If HO is found in any other area than the distal femur it will not prevent my participation in the study.;

12. History of chronic alcohol abuse;

13. Diagnosis of hypercalcemia (high levels of calcium in the blood);

14. Pregnancy;

15. As determined by study staff review of my medications a bisphosphonate for heterotopic ossification (HO), or other medications to treat osteoporosis other than calcium and vitamin D;

16. Current diagnosis of cancer or history of cancer;

17. As determined by study staff review of my medications, prescribed moderate or high dose corticosteroids (>40 mg/d prednisone or an equivalent dose of other corticosteroid medication) for longer than one week, not including drug administered to preserve neurological function at the time of acute SCI; and

18. Life expectancy less than 5 years.

Related Conditions & MeSH terms

• Osteoporosis
• Spinal Cord Injuries

Intervention

Drug:
• Romosozumab
Romosozumab (Amgen Inc., Thousand Oaks, CA) 210mg SQ administered each month
• Denosumab
Denosumab (Amgen Inc., Thousand Oaks, CA) 60 mg SQ administered every six months

Locations

Country	Name	City	State
United States	James J. Peters VA Medical Center	Bronx	New York
United States	Kessler Institute for Rehabilitation	West Orange	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
James J. Peters Veterans Affairs Medical Center	Kessler Institute for Rehabilitation

Country where clinical trial is conducted

United States, 

References & Publications (3)

Cosman F, Crittenden DB, Ferrari S, Khan A, Lane NE, Lippuner K, Matsumoto T, Milmont CE, Libanati C, Grauer A. FRAME Study: The Foundation Effect of Building Bone With 1 Year of Romosozumab Leads to Continued Lower Fracture Risk After Transition to Denosumab. J Bone Miner Res. 2018 Jul;33(7):1219-1226. doi: 10.1002/jbmr.3427. Epub 2018 May 17. — View Citation

Lewiecki EM, Dinavahi RV, Lazaretti-Castro M, Ebeling PR, Adachi JD, Miyauchi A, Gielen E, Milmont CE, Libanati C, Grauer A. One Year of Romosozumab Followed by Two Years of Denosumab Maintains Fracture Risk Reductions: Results of the FRAME Extension Study. J Bone Miner Res. 2019 Mar;34(3):419-428. doi: 10.1002/jbmr.3622. Epub 2018 Dec 3. — View Citation

McClung MR, Brown JP, Diez-Perez A, Resch H, Caminis J, Meisner P, Bolognese MA, Goemaere S, Bone HG, Zanchetta JR, Maddox J, Bray S, Grauer A. Effects of 24 Months of Treatment With Romosozumab Followed by 12 Months of Denosumab or Placebo in Postmenopausal Women With Low Bone Mineral Density: A Randomized, Double-Blind, Phase 2, Parallel Group Study. J Bone Miner Res. 2018 Aug;33(8):1397-1406. doi: 10.1002/jbmr.3452. Epub 2018 May 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density (BMD) of the distal femur metaphysis	BMD at the distal femur metaphysis will be obtained by dual energy X-ray absorptiometry (DXA)	Baseline to 24 months