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Effects of Denosumab on Periprosthetic Bone After Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT01630941
Recruitment Status : Completed
First Posted : June 28, 2012
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
Hans Mallmin, Uppsala University Hospital

Tracking Information
First Submitted Date  ICMJE June 26, 2012
First Posted Date  ICMJE June 28, 2012
Last Update Posted Date April 5, 2017
Actual Study Start Date  ICMJE August 7, 2012
Actual Primary Completion Date January 16, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2012)
Bone Mineral Density [ Time Frame: 12 months ]
Bone mineral density by DXA in Gruen Zone 7 and a sum of Gruen zone 1-7
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2012)
  • Bone mineral Density [ Time Frame: 24 months ]
    BMD, g/cm2, adjacent to the femur implant for Gruen Zone 1-7, 3, 6, and 24 months after surgery
  • Standardised Uptake value [ Time Frame: 6 months ]
    fluoride isotope uptake, measured as (SUV), adjacent to the femoral stem, 3 and 6 months after surgery.
  • Standardised Uptake value [ Time Frame: 6 months ]
    fluoride isotope uptake, measured as SUV adjacent to the acetabular cup 3 and 6 months after surgery
  • Bone Mineral density [ Time Frame: 24 months ]
    BMD adjacent to the acetabular cup during the follow up period, i.e. after 3, 6, 12 and 24 months
  • Bone Mineral Density [ Time Frame: 24 months ]
    BMD at the lumbar spine and at the contra lateral nonoperated hip 6, 12 and 24 months after surgery
  • Standardised Uptake Value [ Time Frame: 6 months ]
    Fluoride isotope uptake measured as SUV at the lumbar spine and at the contra lateral nonoperated hip after 3 and 6 months
  • Biochemical markers for bone metabolism [ Time Frame: 24 months ]
    biochemical markers for bone turnover and the relation to SUV and BMD findings at the proximal femur and acetabulum during the follow up period, i.e. 3, 6, 12 and 24 months after surgery
  • Biochemical markers for bone metabolism in relation to Bone Mineral Density and Standardised Uptake Value [ Time Frame: 24 ]
    biochemical markers for bone turnover and the relation to SUV and BMD findings at anatomical sites not exposed to surgery, i.e. the lumbar spine and the contra lateral hip 3 and 6 months after surgery
  • Biochemical markers for bone metabolism in relation to Bone Mineral Density and Standardised Uptake Value [ Time Frame: 24 ]
    to evaluate the natural course of an uncemented THA on BMD, i.e. the placebo group 3, 6, 12 and 24 months after surgery, SUV i.e. the placebo group 3 and 6 months after surgery and on biochemical markers, i.e. the placebo group 3, 6, 12 and 24 months after surgery
  • Clinical outcome evaluation [ Time Frame: 24 months ]
    to evaluate the patients Quality of Life, measured by Harris Hip score and EQ-5D questionnaires
  • Adverse events [ Time Frame: 24 months ]
    incidence and severity of adverse events (AEs) during the study period
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Denosumab on Periprosthetic Bone After Total Hip Arthroplasty
Official Title  ICMJE Uncemented Total Hip Implant and Subcutaneous Injections of Denosumab for Patients With Osteoarthritis of the Hip. A Randomized Double Blind Placebo Controlled Study on the Effects on Bone Evaluated With DXA, PET/CT and Biochemical Markers
Brief Summary The primary objective is to study the effect of Denosumab on Bone Mineral Density, Standardised Uptake Value and bone metabolism in patients with total hip arthroplasty. The primary hypothesis is to demonstrate that Denosumab is superior to placebo.
Detailed Description

A clinical study with 64 patients, age 35-65 years, with unilateral osteoarthritis of the hip, randomised to two groups of patients, either receiving Denosumab or placebo

The patients will operated with an uncemented total hip arthroplasty with a Continuum acetabular cup with trabecular surface (Tantalum) and longevity Highly Cross-linked Polyethylene liner, Zimmer, Warsaw, IN, USA, and a CFP femoral stem with Titanium surface and a chrome cobalt 28 mm head, Waldemar Link, Hamburg, Germany.

Clinical outcome evaluated by Harris Hip Score and EQ-5D, Bone Mineral Density by DXA, Standardised Uptake Value of Fluoride tracer, by PET/CT and biochemical markers for bone formation and bone resorption will be analyzed together with conventional radiology for implant position and fixation.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Osteoarthritis, Hip
  • Ambulation Difficulty
Intervention  ICMJE Drug: denosumab
Two doses of 60 mg in a solution of 1 ml, given as an subcutaneous injection with a 6 month interval
Other Name: Prolia
Study Arms  ICMJE
  • Active Comparator: Denosumab
    1 ml (60 mg) subcutaneous injection Denosumab give in the posterior part of the upper arm after surgery followed by another injection 6 months later
    Intervention: Drug: denosumab
  • Placebo Comparator: saline
    1 ml subcutaneous injection 0.9% saline give in the posterior part of the upper arm after surgery followed by another injection 6 months later
    Intervention: Drug: denosumab
Publications * Nyström A, Kiritopoulos D, Ullmark G, Sörensen J, Petrén-Mallmin M, Milbrink J, Hailer NP, Mallmin H. Denosumab Prevents Early Periprosthetic Bone Loss After Uncemented Total Hip Arthroplasty: Results from a Randomized Placebo-Controlled Clinical Trial. J Bone Miner Res. 2020 Feb;35(2):239-247. doi: 10.1002/jbmr.3883. Epub 2019 Nov 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 27, 2012)
64
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 30, 2017
Actual Primary Completion Date January 16, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. male or female patient 35-65 years of age with an unilateral OAH requiring a THA and a healthy contralateral hip
  2. body weight ≤110 kg or body mass index (BMI) ≤35 kg/m2
  3. living in the Uppsala County
  4. the eligible patients should have been given oral information, a written Patient Information and signed an Informed Consent

Exclusion Criteria:

  1. on or previously have had bone-specific treatment, e.g. bisphosphonates, raloxifene, parathyroid hormone, strontium ranelate, during the last five years
  2. patients on systemical corticosteroid for more than 3 months should not be considered
  3. patients with diagnosed malignant disease during the last five years or known to have metastasis from malignant disease should be excluded
  4. patients with compromised general conditions and an American Society of Anesthesiologists, ASA-score >31 should not be regarded eligible
  5. patients with known drug or alcohol abuse or regarded as socially dysfunctional, as judged by the investigator, should not be considered for the study
  6. pregnant women or women planning for pregnancy or fertile women (premenopausal) without contraceptives should not be accepted for the study
  7. patients that have been exposed frequently and/or have had large irradiation doses, as judged by the investigator, must not be included in the study.
  8. enrolled in either another investigational drug study, in another investigational device study, or in another investigational study of an approved drug within 30 days prior to Visit 1 of the current study
  9. any condition or laboratory findings which in the opinion of the Investigator makes the patient unsuitable for inclusion (for example claustrophobia)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01630941
Other Study ID Numbers  ICMJE 2011-001481-18
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hans Mallmin, Uppsala University Hospital
Study Sponsor  ICMJE Hans Mallmin
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hans Mallmin, MD, PhD Uppsala University
Study Chair: Nils Hailer, MD, PhD Uppsala University
PRS Account Uppsala University Hospital
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP