Recruiting

Denosumab

Sponsor:

James J. Peters Veterans Affairs Medical Center

Code:

NCT01983475

Conditions

Osteoporosis

Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Denosumab

Placebo (identical Denosumab volume of normal saline)

Study Details

Brief summary:

Sublesional bone loss after acute spinal cord injury (SCI) is sudden, progressive, and dramatic. After depletion of bone mass and the loss of architectural integrity, it may be difficult, if even possible, to restore skeletal mass and strength. Denosumab is a relative new, highly potent anti-resorptive agent that has proven efficacy in postmenopausal osteoporosis to improve bone mass and in solid tumor patients to prevent a skeletal-related event to a greater extent than that with bisphosphonate administration. In persons with complete motor lesions, bisphosphonates have not been effective at reducing bone loss at the knee, the site of greatest relevance because of its increased risk of fracture. Anti-RANKL therapy appears to be more potent than bisphosphonates in animal models of bone loss due to immobilization, suggesting that treatment with denosumab may prove to be an efficacious therapy for persons with acute SCI to preserve bone mass and strength.

Conditions

Osteoporosis

Spinal Cord Injury

Study ID

NCT01983475

Start date

Jan, 2015

Status verified date

Mar, 2019

Completion date

May, 2020

Anticipated

Primary completion date

May, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Complete motor SCI \[American Spinal Injury Association Impairment Scale (AIS) grade A and B\];
2. Duration of injury <12 weeks; and
3. Males between the ages of 18 and 65 years old and females between the ages of 18 and 50 years old.

Exclusion Criteria:

1. Extensive life-threatening injuries in addition to SCI;
2. Acute fracture or extensive bone trauma;
3. History of prior bone disease (Paget's hyperparathyroidism, osteoporosis, etc.)
4. Post menopausal women;
5. Men with known hypogonadism prior to SCI;
6. Anabolic or Steroid hormonal therapy; within the past year and longer than six months;
7. Hyperthyroidism;
8. Cushing's disease or syndrome;
9. Severe underlying chronic disease;
10. Heterotopic ossification of the knee region (HO limited to the hip region only will not exclude subject participation);
11. History of chronic alcohol abuse;
12. Diagnosis of Hypocalcemia;
13. Pregnancy;
14. Existing dental condition/dental infection
15. Any patient taking a bisphosphonate for heterotopic ossification (HO);
16. Current diagnosis of cancer or history of cancer; and
17. Any patient receiving moderate or high dose corticosteroids (>40 mg/d prednisone or an equivalent dose of other corticosteroid) for longer than one week, not including drug administered in an attempt to preserve neurological function at the time of acute SCI.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

A group of participants will be randomized to the placebo group and will receive the identical volume of normal saline at parallel time points.

experimental: Denosumab

A group of participants will be randomized to the experimental group and will have Denosumab (Prolia, 60 mg SC) administered at baseline, 6 and 12 months.

Interventions

Denosumab

In clinical trials, denosumab (Amgen Inc., Thousand Oaks, CA), has been shown to be more potent in reducing osteoclastosis and function than bisphosphonates.39,40 The rate of bone loss in the lower extremity at sites of interest in patients with acute SCI has been reported to be several-fold greater than the rate of bone loss in postmenopausal women not prescribed antiresorptive medications, which is about 3-5% per year.11,50,51 The dose of denosumab chosen for our protocol in patients after acute SCI will be the same dose that has been shown to be efficacious to treat postmenopausal osteoporosis (60 mg SQ q 6 months).

Placebo (identical Denosumab volume of normal saline)

The placebo group will receive the identical volume of normal saline at parallel time points.

Primary outcome measure

  • Bone mineral density (BMD) of the distal femur [ Time Frame: Baseline, 1, 3, 6, 12, and 18 months after Denosumab administration ]

Central Contacts and Locations

Central contacts

Christopher M Cirnigliaro, M.S.

973-731-3900christopher.cirnigliaro@va.gov

Locations

Kessler Institute for Rehabilitation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Principal Investigator:

Steven C Kirshblum, M.D.

James J. Peters VA Medical Center

Recruiting

Bronx, New York, United States, 10468

Contacts

More Information

Sponsor

James J. Peters Veterans Affairs Medical Center

Last update posted

Mar 8, 2019

Last verified

Mar, 2019

Keywords

  • Spinal Cord Injury
  • Denosumab
  • Osteoporosis
  • Dual Energy X-ray Absorptiometry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-03. This information was provided to ClinicalTrials.gov by James J. Peters Veterans Affairs Medical Center on 2019-03-08.