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Longjohn Amgen Study - Effect of Denosumab... (EDRPBLFHR)

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ClinicalTrials.gov Identifier: NCT02444585
Recruitment Status : Withdrawn (No participants enrolled in the trial)
First Posted : May 14, 2015
Last Update Posted : November 10, 2020
Sponsor:
Collaborator:
Orthopaedic Institute for Children
Information provided by (Responsible Party):
Donald Longjohn, University of Southern California

Brief Summary:

The overall objective of the proposed study is to quantify bone loss around non-cemented total hip replacement femoral and acetabular components using DEXA analysis in patients receiving Prolia (denosumab) in the first year of follow up after total hip joint replacement surgery, and to compare this to bone loss in control hip replacement patients receiving a placebo.

The primary outcome variable will be the difference in loss of bone mineral density between the experimental group taking denosumab and the placebo control group, calculated as a percentage, in Gruen Zone 7, the proximal medial calcar region of the femur, over a follow-up period of 12 post-operative months.

The secondary objectives will be to assess the following variables:

  • Bone turnover differences between the experimental group taking denosumab and the placebo control group, utilizing serum C-terminal cross-linking telopeptides of type I collagen (CTX-I) (bone resorption) and N-terminal propeptides of type I procollagen (P1NP) (bone formation).
  • Difference in loss of bone mineral density between the experimental group taking denosumab and the placebo control group, calculated as a percentage, in each of Gruen Zones 1 through 6, periprosthetic femur.
  • Difference in loss of bone mineral density between the experimental group taking denosumab and the placebo control group, calculated as a percentage, in each of DeLee and Charnley's Zones 1 through 3, periprosthetic acetabulum.

Exploratory objectives will be to assess difference in loss of bone mineral density in the contralateral, or non-operated femur for both experimental and control groups, and to determine the role that covariates such as weight, gender, age, baseline BMD, and implant type have on percent change in BMD at 12 months.


Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Hip Drug: Denosumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Denosumab in Reversing Periprosthetic Bone Loss Following Hip Replacement
Actual Study Start Date : February 28, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Denosumab

Arm Intervention/treatment
Experimental: Denosumab
Drug for prevention of bone loss
Drug: Denosumab
Intended to prevent periprosthetic loss of bone mineral density
Other Name: Prolia

Placebo Comparator: Control
Hip Replacement Patient without Drug
Drug: Denosumab
Intended to prevent periprosthetic loss of bone mineral density
Other Name: Prolia




Primary Outcome Measures :
  1. Change in Bone Mineral Density [ Time Frame: One Year ]
    The primary outcome variable will be the difference in loss of bone mineral density between the experimental group taking denosumab and the placebo control group.


Secondary Outcome Measures :
  1. Bone Turnover Markers [ Time Frame: One Year ]
    Bone turnover differences between the experimental group taking denosumab and the placebo control group.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Inclusion criteria will allocate patients undergoing elective total hip replacement due to osteoarthritis. The prosthetic device will be a standard, non-cemented tapered total hip replacement, such as an Alloclassic® (Zimmer, Inc., Warsaw, IN) or a similarly shaped implant of the same material (titanium alloy) such as the Summit Hip (Depuy, Inc., Warsaw, IN). Subjects will be between 55 and 75 years of age. Both genders will be included. Prior to surgery, creatinine clearance, calcium, and vitamin D will be checked. Creatinine clearance rates must be above 30 ml/min, vitamin D serum levels must be greater than 12 ng/ml, and patients cannot be hypocalcemic. If vitamin D serum levels are below normal (30ng/ml) the 1000 mg of calcium and at least 1000 Units of vitamin D, recommended by the surgeon at the time of operation will likely be sufficient to correct this problem.

Exclusion Criteria:

  • Current use of medications that may affect bone and mineral metabolism (e.g., glucocorticoids, diuretics, estrogen, oral contraceptives, tamoxifen, bisphosphonates, raloxifene, calcitonin, PTH, anticonvulsants, immunosuppressants), and subjects with a history of any disease that affects bone and mineral metabolism (e.g., thyrotoxicosis, hyperparathyroidism, hypocalcemia hypoparathyroidism, chronic renal failure, Cushing's disease, rheumatoid arthritis, hematological disease, alcohol abuse > 3 drinks a day), cancer. Additionally, patients who are taking immunosuppressants will be excluded. Patients who have been treated with anti-TNF in the past 3 months will be excluded. Patients with hypocalcemia or patients who have used bisphosphonates in the 2-3 years prior to the surgery will be excluded. Additionally, patients with creatinine clearance rates below 30 ml/minwill be excluded, as will patients with severe vitamin D deficiencies (<12 ng/ml). Patients with decreased hepatic function as measured by AST, ALT, Alkaline Phosphatase or Total Bilirubin will be excluded from the study. Patients who have had any solid organ or bone marrow transplants will be excluded. Patients who have a history of malignancy within the past 5 years, with the exception of basal cell carcinoma or cervical carcinoma in situ, will be excluded. Additionally, as the incidence of serious infections may be higher in patients treated with denosumab, patients with poorly controlled diabetes/HbA1C will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02444585


Locations
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United States, California
Keck Medicine of USC
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Orthopaedic Institute for Children
Investigators
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Principal Investigator: Donald Longjohn, MD University of Southern California
Study Director: Edward Ebramzadeh, PhD Orthopaedic Institute for Children (Orthopaedic Hospital)
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Responsible Party: Donald Longjohn, Assistant Professor of Clinical Orthopaedics, University of Southern California
ClinicalTrials.gov Identifier: NCT02444585    
Other Study ID Numbers: HS-14-00135
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs