Overview

This trial is active, not recruiting.

Conditions osteoarthritis, hip, ambulation difficulty
Treatment denosumab
Phase phase 2
Sponsor Hans Mallmin
Start date March 2012
End date January 2017
Trial size 64 participants
Trial identifier NCT01630941, 2011-001481-18

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
Arm
(Active Comparator)
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
denosumab Prolia
Two doses of 60 mg in a solution of 1 ml, given as an subcutaneous injection with a 6 month interval
(Placebo Comparator)
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
denosumab Prolia
Two doses of 60 mg in a solution of 1 ml, given as an subcutaneous injection with a 6 month interval

Primary Outcomes

Measure
Bone Mineral Density
time frame: 12 months

Secondary Outcomes

Measure
Bone mineral Density
time frame: 24 months
Standardised Uptake value
time frame: 6 months
Standardised Uptake value
time frame: 6 months
Bone Mineral density
time frame: 24 months
Bone Mineral Density
time frame: 24 months
Standardised Uptake Value
time frame: 6 months
Biochemical markers for bone metabolism
time frame: 24 months
Biochemical markers for bone metabolism in relation to Bone Mineral Density and Standardised Uptake Value
time frame: 24
Biochemical markers for bone metabolism in relation to Bone Mineral Density and Standardised Uptake Value
time frame: 24
Clinical outcome evaluation
time frame: 24 months
Adverse events
time frame: 24 months

Eligibility Criteria

Male or female participants from 35 years up to 65 years old.

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)

Additional Information

Official title 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
Principal investigator Hans Mallmin, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Uppsala University Hospital.