Prolia medication in enhancement of implant healing in female patients after hip replacement

• Conditions: Hip osteoarthritis; MedDRA version: 14.1Level: LLTClassification code 10020104Term: Hip total replacementSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-000628-14-FI
• Lead Sponsor: Turku University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-22
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Postmenopausal women, age: = 60 years to = 85 years at randomization
• Degenerative primary hip OA as the indication of hip replacement
• Signed informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 68

Exclusion Criteria

• Presence of severe osteoporosis (T-score less than -4.0)
• Presence of Dorr C-type geometric change of the proximal femur
• Evidence of secondary osteoporosis
• Clinical or laboratory evidence of hepatic disease
• Laboratory evidence of hypocalcaemia
• Vitamin D deficiency (serum 25-OH(D) < 12 ng/mL)
• Disorders of parathyroid function
• Uncontrolled hyperthyroidism or hypothyroidism
• History of malignancy, radiotherapy or chemotherapy for malignancy (except basal cell carcinoma of the skin) within the last 5 years
• History of osteonecrosis of the jaw
• History of recent tooth extraction or other dental surgery and/or invasive dental work planned in the next 2 years
• Severe asthma or chronic obstructive pulmonary disease
• Use within 12 months of drugs that affect bone metabolism such as ant-osteoporotic agents (including SERMS), estrogens, testosterone, and anti-epileptics
• Rheumatoid arthritis or any other inflammatory arthritis
• History of skeletal disorder, such as Paget’s disease or osteomalasia
• Alcohol abuse
• General
o Mental, neurological or other conditions that may affect the ability to perform functional or clinical assessments required by the protocol
o Subjects with known sensitivity or intolerance to any of the products to be administered
o Subject will not be available for protocol-required study visits, to the best of the subject’s and investigator’s knowledge
o Any other condition that, in the judgement of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: The secondary hypothesis is that denosumab is effective in enhancement of bone bonding (osseointegration) of cementless hip prosthesis and prevents delayed bonding in osteoporotic postmenopausal women;Primary end point(s): The primary endpoint is the percent change from baseline in periprosthetic BMD of the proximal femur ;Main Objective: The primary hypothesis for this trial is that denosumab compared with placebo is effective in preventing periprosthetic bone loss in the proximal femur of female patients after total hip replacement ;Timepoint(s) of evaluation of this end point: 48 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The change from baseline in three-dimensional translational and rotatory migration of the femoral stem;Timepoint(s) of evaluation of this end point: 48 weeks