Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
24 participants
INTERVENTIONAL
2015-01-31
2020-05-31
Brief Summary
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Detailed Description
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Twenty-four subjects with acute, motor complete SCI (≤12 weeks) who have been admitted to the Kessler Institute for Rehabilitation (KIR) will be recruited for participation. The age of study participation will be males between the ages of 18 and 65 years old and females between the ages of 18 and 50 years old. Primary outcome measure will be BMD as measured by DXA and microarchitecture as measured by pQCT at the hip and knee.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Placebo (identical Denosumab volume of normal saline)
The placebo group will receive the identical volume of normal saline at parallel time points.
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.
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).
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Kessler Institute for Rehabilitation
INDUSTRY
James J. Peters Veterans Affairs Medical Center
FED
Responsible Party
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William A. Bauman, M.D.
Director VA RR&D Center of Excellence for the Medical Consequences of SCI
Principal Investigators
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William A Bauman, M.D.
Role: PRINCIPAL_INVESTIGATOR
James J. Peters VA Medical Center
Steven C Kirshblum, M.D.
Role: PRINCIPAL_INVESTIGATOR
Kessler Institute for Rehabilitation
Locations
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Kessler Institute for Rehabilitation
West Orange, New Jersey, United States
James J. Peters VA Medical Center
The Bronx, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Reid IR, Miller PD, Brown JP, Kendler DL, Fahrleitner-Pammer A, Valter I, Maasalu K, Bolognese MA, Woodson G, Bone H, Ding B, Wagman RB, San Martin J, Ominsky MS, Dempster DW; Denosumab Phase 3 Bone Histology Study Group. Effects of denosumab on bone histomorphometry: the FREEDOM and STAND studies. J Bone Miner Res. 2010 Oct;25(10):2256-65. doi: 10.1002/jbmr.149.
Kendler DL, Roux C, Benhamou CL, Brown JP, Lillestol M, Siddhanti S, Man HS, San Martin J, Bone HG. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women transitioning from alendronate therapy. J Bone Miner Res. 2010 Jan;25(1):72-81. doi: 10.1359/jbmr.090716.
Related Links
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Spinal Cord Damage Research Center
Other Identifiers
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113536
Identifier Type: -
Identifier Source: org_study_id
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