Denosumab in Enhancement of Bone Bonding of Hip Prosthesis in Postmenopausal Women

NCT01926158 | Completed Phase 4 DMC FDA Drug

• 2 other identifiers: ISS 201097142011-000628-14
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial will evaluate the efficacy of an antiresorptive osteoporosis drug (denosumab) in prevention of periprosthetic bone loss and in promotion of implant osseointegration (bone bonding) in postmenopausal women after total hip replacement. The investigators assume that denosumab prevents periprosthetic bone loss and enhances bone bonding of the hip stem in postmenopausal women.

Conditions

Hip Osteoarthritis

Keywords

Denosumab; Osteoporosis; Hip replacement; Osteoarthritis; Radiostereometric analysis (RSA); Dual energy X-ray absorptiometry (DXA)

Outcome Measures

Primary Outcomes (1)

• Periprosthetic bone mineral density (BMD)

  Periprosthetic BMD of the proximal femur will be measured according to seven Gruen zones and compared with the baseline value

  48 weeks

Secondary Outcomes (1)

• Radiostereometric analysis (RSA) of prosthesis stem migration

  48 weeks

Other Outcomes (1)

• Functional recovery

  48 weeks

Study Arms (2)

Denosumab

EXPERIMENTAL

Subcutaneous injection of denosumab 60 mg 4 weeks before surgery and 22 weeks after surgery

Drug: Denosumb

Placebo

PLACEBO COMPARATOR

Subcutaneous injection of placebo 4 weeks before surgery and 22 weeks after surgery

Drug: Placebo (for denosumab)

Interventions

Denosumb DRUG

Prefilled syringe of 1 mL denosumab solution

Also known as: Brand name: Prolia

Denosumab

Placebo (for denosumab) DRUG

Also known as: Prefilled syringe of 1 mL placebo solution

Placebo

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Presence of severe osteoporosis (T-score less than -4.0 and a previous fracture)
• 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
• History of solid organ or bone marrow transplant
• Use within 12 months of drugs that affect bone metabolism such as ant-osteoporotic agents (including SERMS), estrogens, testosterone, and anti-epileptics:
• Cumulative dose of 500 mg prednisone or equivalent within the last 6 months

Sponsors & Collaborators

• Turku University Hospital: lead
• Amgen: collaborator

Study Sites (1)

Turku University Hospital

Turku, 20521, Finland

Location

Related Publications (6)

• Aro HT, Alm JJ, Moritz N, Makinen TJ, Lankinen P. Low BMD affects initial stability and delays stem osseointegration in cementless total hip arthroplasty in women: a 2-year RSA study of 39 patients. Acta Orthop. 2012 Apr;83(2):107-14. doi: 10.3109/17453674.2012.678798. Epub 2012 Apr 11.

  PMID: 22489886 BACKGROUND

• Moritz N, Alm JJ, Lankinen P, Makinen TJ, Mattila K, Aro HT. Quality of intertrochanteric cancellous bone as predictor of femoral stem RSA migration in cementless total hip arthroplasty. J Biomech. 2011 Jan 11;44(2):221-7. doi: 10.1016/j.jbiomech.2010.10.012. Epub 2010 Nov 11.

  PMID: 21074160 BACKGROUND

• Alm JJ, Makinen TJ, Lankinen P, Moritz N, Vahlberg T, Aro HT. Female patients with low systemic BMD are prone to bone loss in Gruen zone 7 after cementless total hip arthroplasty. Acta Orthop. 2009 Oct;80(5):531-7. doi: 10.3109/17453670903316801.

  PMID: 19916684 BACKGROUND

• Makinen TJ, Alm JJ, Laine H, Svedstrom E, Aro HT. The incidence of osteopenia and osteoporosis in women with hip osteoarthritis scheduled for cementless total joint replacement. Bone. 2007 Apr;40(4):1041-7. doi: 10.1016/j.bone.2006.11.013. Epub 2007 Jan 17.

  PMID: 17239668 BACKGROUND

• Makinen TJ, Koort JK, Mattila KT, Aro HT. Precision measurements of the RSA method using a phantom model of hip prosthesis. J Biomech. 2004 Apr;37(4):487-93. doi: 10.1016/j.jbiomech.2003.09.004.

  PMID: 14996560 BACKGROUND

• Nazari-Farsani S, Finnila S, Moritz N, Mattila K, Alm JJ, Aro HT. Is Model-based Radiostereometric Analysis Suitable for Clinical Trials of a Cementless Tapered Wedge Femoral Stem? Clin Orthop Relat Res. 2016 Oct;474(10):2246-53. doi: 10.1007/s11999-016-4930-0. Epub 2016 Jun 22.

  PMID: 27334320 RESULT

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoporosis; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases, Metabolic; Bone Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Hannu T Aro, MD, PhD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2013
• First Posted: August 20, 2013
• Study Start: December 1, 2013
• Primary Completion: February 4, 2017
• Study Completion: December 31, 2017
• Last Updated: April 30, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)