Hip OsteoarthritisPhase 4ProliaHipNCT01926158
Denosumab in Enhancement of Bone Bonding of Hip Prosthesis in Postmenopausal Women
A Phase 4 study testing Denosumb in people with Hip Osteoarthritis, run by Turku University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years, women only
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Denosumb
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2013to 31 Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women, age: ≥ 60 years to ≤ 85 years at randomization
- Degenerative primary hip osteoarthritis as the indication of hip replacement
- Signed informed consent
Who cannot join
- 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)
Show all 33Show fewer
- 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
- Ever use of oral or iv bisphosphonates
- Ever use of strontium ranelate or fluoride
- Use of the following medications:
- chronic systemic ketoconazole
- androgens
- cinacalcet
- aluminum
- lithium
- protease inhibitors
- gonadotropin-releasing hormone agonists
- Rheumatoid arthritis or any other inflammatory arthritis
- History of skeletal disorder, such as Paget's disease or osteomalacia
- Alcohol abuse
- General
- Mental, neurological or other conditions that may affect the ability to perform functional or clinical assessments required by the protocol
- Subjects with known sensitivity or intolerance to any of the products to be administered (calcium and D-vitamin supplements, denosumab)
- Subject will not be available for protocol-required study visits, to the best of the subject's and investigator's knowledge
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Denosumab in Enhancement of Bone Bonding of Hip Prosthesis in Postmenopausal Women: a Randomized, Double-blind, Placebo-controlled Study
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.
Read the detailed description
This is a randomized, double-blind and placebo-controlled trial to evaluate the efficacy of denosumab on the biologic incorporation of cementless hip prosthesis. The study population consists of sixty-eight postmenopausal female patients, who are scheduled to have cementless total hip replacement (THA) for primary hip osteoarthritis. The patients will be randomly assigned to receive a subcutaneous injection of denosumab 60 mg or placebo four weeks before surgery and 22 weeks after surgery. The primary hypothesis is that denosumab is effective in preventing periprosthetic bone loss in the proximal femur as measured by DXA. The secondary hypothesis is that denosumab is effective in enhancement of bone bonding (osseointegration) of cementless femoral stems, as measured by model-based radiostereometric analysis.
- Conditions
- Hip Osteoarthritis
- Being tested
- Denosumb, Placebo (for denosumab)
- Keywords
- Denosumab, Osteoporosis, Hip replacement, Osteoarthritis, Radiostereometric analysis (RSA), Dual energy X-ray absorptiometry (DXA)
- Medical subject headings
- Osteoarthritis, Hip, Osteoporosis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumbDrug
Also called Brand name: Prolia
Prefilled syringe of 1 mL denosumab solution
Placebo (for denosumab)Drug
Also called Prefilled syringe of 1 mL placebo solution
| Study group | Role | What they receive |
|---|---|---|
| Denosumab | Experimental | Subcutaneous injection of denosumab 60 mg 4 weeks before surgery and 22 weeks after surgery Receives: Drug: Denosumb |
| Placebo | Placebo comparator | Subcutaneous injection of placebo 4 weeks before surgery and 22 weeks after surgery Receives: Drug: Placebo (for denosumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 weeks
Secondary outcomes (1)
Radiostereometric analysis (RSA) of prosthesis stem migration
The translatory and rotatory migration of the femoral stem will be measured by means of model-based RSA and compared with the position at the baseline
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startDec 2013
- Primary completion4 Feb 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Hannu T Aro, MD, PhD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926158
- Sponsor's protocol ID
- ISS 20109714
- Other IDs
- 2011-000628-14
- Acronym
- ProliaHip
- Status last verified
- Apr 2018
- First submitted
- 16 Aug 2013
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22489886Moritz 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.
PubMed 21074160Alm 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.
PubMed 19916684Makinen 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.
PubMed 17239668Makinen 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.
PubMed 14996560Nazari-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.
PubMed 27334320
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Denosumab in Enhancement of Bone Bonding of Hip Prosthesis in Postmenopausal Women: a Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT01926158
- Acronym / sponsor ID
- ProliaHip / ISS 20109714
- Conditions
- Hip Osteoarthritis
- Keywords
- Denosumab, Osteoporosis, Hip replacement, Osteoarthritis, Radiostereometric analysis (RSA), Dual energy X-ray absorptiometry (DXA)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Amgen
- Study start
- Dec 2013 (actual)
- Primary completion
- 4 Feb 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 20 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized, double-blind and placebo-controlled trial to evaluate the efficacy of denosumab on the biologic incorporation of cementless hip prosthesis. The study population consists of sixty-eight postmenopausal female patients, who are scheduled to have cementless total hip replacement (THA) for primary hip osteoarthritis. The patients will be randomly assigned to receive a subcutaneous injection of denosumab 60 mg or placebo four weeks before surgery and 22 weeks after surgery. The primary hypothesis is that denosumab is effective in preventing periprosthetic bone loss in the proximal femur as measured by DXA. The secondary hypothesis is that denosumab is effective in enhancement of bone bonding (osseointegration) of cementless femoral stems, as measured by model-based radiostereometric analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denosumab | Experimental | Drug: DenosumbSubcutaneous injection of denosumab 60 mg 4 weeks before surgery and 22 weeks after surgery |
| Placebo | Placebo comparator | Drug: Placebo (for denosumab)Subcutaneous injection of placebo 4 weeks before surgery and 22 weeks after surgery |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal women, age: ≥ 60 years to ≤ 85 years at randomization
- Degenerative primary hip osteoarthritis as the indication of hip replacement
- Signed informed consent
Key exclusion criteria (33 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DenosumbAlso: Brand name: ProliaPrefilled syringe of 1 mL denosumab solution | Drug | Denosumab |
| Placebo (for denosumab)Also: Prefilled syringe of 1 mL placebo solution | Drug | Placebo |
Primary outcome
Periprosthetic bone mineral density (BMD)
Time frame: 48 weeks
Periprosthetic BMD of the proximal femur will be measured according to seven Gruen zones and compared with the baseline value
1 secondary outcome
Radiostereometric analysis (RSA) of prosthesis stem migration
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
- Background: PubMed 22489886Aro 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.
- Background: PubMed 21074160Moritz 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.
- Background: PubMed 19916684Alm 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.
- Background: PubMed 17239668Makinen 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.
- Background: PubMed 14996560Makinen 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.
- Results publication: PubMed 27334320Nazari-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.
- Individual participant dataSharing planned: No
Related trials for Hip Osteoarthritis
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannu T Aro, MD, PhD principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Denosumb in people with Hip Osteoarthritis, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periprosthetic bone mineral density (BMD) (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01926158, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2018.