OsteolysisPhase 2NCT02299817
Denosumab for Treating Periprosthetic Osteolysis.
A Phase 2 study testing Denosumab in people with Osteolysis, run by Olof Skoldenberg at 1 site in Sweden.
Trial summary
The main objective is to study the efficacy of denosumab in reducing wear-induced osteolysis around uncemented acetabular implants used in total hip arthroplasty. Patients included in the study will receive the same dose of 60 mg denosumab or placebo (1 ml solution) for a total of 6 doses with start on day one and… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteolysis
- What is being tested?
- Denosumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2015to Feb 2021
- Phase
- Phase 2
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-85 years
- Short Portable Mental Status Questionnaire (SPMSQ) also named pfeiffers test ≥7
- Male and females
- The primary total hip arthroplasty performed between 7 to 20 years before inclusion.
- The primary total hip arthroplasty performed due to osteoarthritis or congenital dysplasia of the hip.
- Uncemented cup fixation
- Baseline osteolytic lesion of at least 4 cm³ and at most 40 cm³ around an uncemented acetabular component with a polyethylene liner.
- Participant is willing and able to follow study protocol and has provided informed consent prior to any study specific procedures.
Who cannot join
- For women of childbearing potential: Subject refuses to use 1 highly effective method of contraception (contraceptive pill, intra uterine contraceptive device) for the duration of the study and for 10 months after the last dose of study medication.
- For males with a partner of childbearing potential: Subject refuses to use a condom for the duration of the study and for 10 months after the last dose of study medication.
- For males with a partner who is pregnant: Subject refuses to use a condom for the duration of the study and for 10 months after the last dose of study medication.
- Pain in the operated hip (because the presence of hip pain in combination with an osteolytic lesion is an indication for revision surgery). VAS >3
- Previous revision surgery of the hip i.e. exchange of any inplant after the primary surgery
- Inflammatory arthritis
Show all 32Show fewer
- Previous participation in clinical trials with denosumab or administration of commercial denosumab (Prolia™ or Xgeva™)
- Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).
- Treatment with any intravenous bisphosphonate, fluoride (except for dental treatment) or strontium ranelate within 5 years prior to inclusion.
- Treatment with any oral bisphosphonate within 1 year prior to inclusion.
- Treatment with cortisol or cytostatic drugs within 6 months prior to inclusion.
- Administration of any of the following treatments 3 months prior to screening:
- Anabolic steroids or testosterone
- Glucocorticosteroids (≥ 5 mg prednisone equivalent per day for more than 10 days or a total cumulative dose of ≥ 50 mg)
- Calcitonin
- Calcitriol or vitamin D derivatives [vitamin D contained in supplements or multivitamins is allowed]
- Other bone active drugs including anti convulsive (except benzodiazepines) and heparin
- Chronic systemic ketoconazole, adrenocorticotrophic hormone, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, gonadotropin-releasing hormone agonists.
- Androgen deprivation therapy
- Hypocalcaemia.
- Bone metabolic disorders (such as OI, PHPT, Paget)
- History of osteonecrosis of the jaw and/or recent tooth extraction or dental surgery; or planned invasive dental procedures during the study
- Serum 25-OH D <20 ng/ml
- Significant malabsorption including Celiac Disease, Short Bowel Syndrome, Crohn's Disease, Previous Gastric Bypass.
- Active cancer and/or malignancy in last 5 years (except cervical carcinoma in situ or basal cell carcinoma)
- History of solid organ or bone marrow transplant.
- Hypersensitivity to any components of study drug.
- Intolerance to calcium supplements.
- Pregnancy and/or currently lactating.
- Significantly impaired renal function as determined by a derived glomerular filtration rate (GFR) using Cockcroft Gault formula of 30 mL/min/1.73 m2
- Elevated transaminases ≥ 2.0 x upper limit of normal (ULN); Elevated total bilirubin (TBL) > 1.5 x ULN.
- Any condition or illness (acute, chronic, or history), which in the opinion of the Investigator might interfere with the evaluation of efficacy and safety during the study or may otherwise compromise the safety of the subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Denosumab for Treating Periprosthetic Osteolysis After Uncemented Total Hip Arthroplasty A Randomized, Double-blind, Placebo-controlled Trial Using Volumetric Computed Tomography
The main objective is to study the efficacy of denosumab in reducing wear-induced osteolysis around uncemented acetabular implants used in total hip arthroplasty. Patients included in the study will receive the same dose of 60 mg denosumab or placebo (1 ml solution) for a total of 6 doses with start on day one and every 6 months with last treatment at 30 months. The primary endpoint will be the change in volume of the osteolytic lesion over 3 years measured (measured with 3D-CT in cm³).
- Conditions
- Osteolysis
- Being tested
- Denosumab, Placebo
- Medical subject headings
- Osteolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
Also called Prolia
Prolia is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men who have an increased risk of fracture (broken bones). In women who have been through the menopause Prolia reduces the risk of fractures in the spine and elsewhere in the body, including in the hip.
Prolia is also used to treat bone loss in men receiving treatment for prostate cancer that increases their risk of fracture. Prolia reduces the risk of fractures in the spine.
Recently denosumab was found to be effective in preventing osteoporosis related fractures in post-menopausal women by blocking RANKL and thereby inhibiting the development and activity of osteoclast.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Denosumab | Active comparator | Patients will receive a dose of 60 mg denosumab (1 ml solution) for a total of 6 doses with start on day one and every 6 months with last treatment at 30 months. Receives: Drug: Denosumab |
| Placebo | Placebo comparator | Patients will receive a dose of placebo (1 ml solution) for a total of 6 doses with start on day one and every 6 months with last treatment at 30 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of the osteolytic lesion
The change in volume of the osteolytic lesion over 3 years (measured with 3D-CT in cm³) is the primary endpoint variable: E〖fficacy〗_(3 years)=〖Volume〗_(3 years)-〖Volume〗_baseline.
Measured: 3 years
Secondary outcomes (3)
Volume of the osteolytic lesion
The change in volume of the osteolytic lesion over 2 years (measured with 3D-CT in cm³) 〖Efficacy〗_(2 years)=〖Volume〗_(2 years)-〖Volume〗_baseline.
Measured: 2 years
Percentage change of the lesion over the study period
Percentage change of the lesion over the study period
Measured: 3 years
Adverse events
Occurrence of AE´s
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startAug 2015
- Primary completionJan 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteolysisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olof Skoldenberg
- Sponsor type
- University, hospital or other
- Collaborators
- Danderyd Hospital
- Responsible party
- Sponsor-investigator, Olof Skoldenberg, Danderyd Hospital
- Investigators
- Olof Sköldenberg, MD, Ph.D, Study director, Danderyds Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299817
- Sponsor's protocol ID
- EudraCT No: 2013-004940-48
- Status last verified
- Feb 2019
- First submitted
- 20 Nov 2014
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Axenhus M, Boden H, Kelly-Pettersson P, Skoldenberg O. Denosumab for treating periprosthetic osteolysis: a feasibility study. BMC Res Notes. 2025 Apr 8;18(1):151. doi: 10.1186/s13104-025-07216-0.
PubMed 40200363Skoldenberg O, Rysinska A, Eisler T, Salemyr M, Boden H, Muren O. Denosumab for treating periprosthetic osteolysis; study protocol for a randomized, double-blind, placebo-controlled trial. BMC Musculoskelet Disord. 2016 Apr 23;17:174. doi: 10.1186/s12891-016-1036-5.
PubMed 27108405
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Denosumab for Treating Periprosthetic Osteolysis After Uncemented Total Hip Arthroplasty A Randomized, Double-blind, Placebo-controlled Trial Using Volumetric Computed Tomography
- ClinicalTrials.gov ID
- NCT02299817
- Acronym / sponsor ID
- EudraCT No: 2013-004940-48
- Conditions
- Osteolysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Olof SkoldenbergUniversity, hospital or other
- Collaborators
- Danderyd Hospital
- Study start
- Aug 2015
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 24 Nov 2014 (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.
The main objective is to study the efficacy of denosumab in reducing wear-induced osteolysis around uncemented acetabular implants used in total hip arthroplasty. Patients included in the study will receive the same dose of 60 mg denosumab or placebo (1 ml solution) for a total of 6 doses with start on day one and every 6 months with last treatment at 30 months. The primary endpoint will be the change in volume of the osteolytic lesion over 3 years measured (measured with 3D-CT in cm³).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denosumab | Active comparator | Drug: DenosumabPatients will receive a dose of 60 mg denosumab (1 ml solution) for a total of 6 doses with start on day one and every 6 months with last treatment at 30 months. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive a dose of placebo (1 ml solution) for a total of 6 doses with start on day one and every 6 months with last treatment at 30 months. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 40-85 years
- Short Portable Mental Status Questionnaire (SPMSQ) also named pfeiffers test ≥7
- Male and females
- The primary total hip arthroplasty performed between 7 to 20 years before inclusion.
- The primary total hip arthroplasty performed due to osteoarthritis or congenital dysplasia of the hip.
Key exclusion criteria (32 listed)
- For women of childbearing potential: Subject refuses to use 1 highly effective method of contraception (contraceptive pill, intra uterine contraceptive device) for the duration of the study and for 10 months after the last dose of study medication.
- For males with a partner of childbearing potential: Subject refuses to use a condom for the duration of the study and for 10 months after the last dose of study medication.
- For males with a partner who is pregnant: Subject refuses to use a condom for the duration of the study and for 10 months after the last dose of study medication.
- Pain in the operated hip (because the presence of hip pain in combination with an osteolytic lesion is an indication for revision surgery). VAS >3
- Previous revision surgery of the hip i.e. exchange of any inplant after the primary surgery
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 |
|---|---|---|
| DenosumabAlso: ProliaProlia is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men who have an increased risk of fracture (broken bones). In women who have been through the menopause Prolia reduces the risk of fractures in the spine and elsewhere in the body, including in the hip. Prolia is also used to treat bone loss in men receiving treatment for prostate cancer that increases their risk of fracture. Prolia reduces the risk of fractures in the spine. Recently denosumab was found to be effective in preventing osteoporosis related fractures in post-menopausal women by blocking RANKL and thereby inhibiting the development and activity of osteoclast. | Drug | Denosumab |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Volume of the osteolytic lesion
Time frame: 3 years
The change in volume of the osteolytic lesion over 3 years (measured with 3D-CT in cm³) is the primary endpoint variable: E〖fficacy〗_(3 years)=〖Volume〗_(3 years)-〖Volume〗_baseline.
3 secondary outcomes
Volume of the osteolytic lesion
Time frame: 2 years
Percentage change of the lesion over the study period
Time frame: 3 years
Adverse events
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
- Derived from this study: PubMed 40200363Axenhus M, Boden H, Kelly-Pettersson P, Skoldenberg O. Denosumab for treating periprosthetic osteolysis: a feasibility study. BMC Res Notes. 2025 Apr 8;18(1):151. doi: 10.1186/s13104-025-07216-0.
- Derived from this study: PubMed 27108405Skoldenberg O, Rysinska A, Eisler T, Salemyr M, Boden H, Muren O. Denosumab for treating periprosthetic osteolysis; study protocol for a randomized, double-blind, placebo-controlled trial. BMC Musculoskelet Disord. 2016 Apr 23;17:174. doi: 10.1186/s12891-016-1036-5.
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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.
Olof Sköldenberg, MD, Ph.D study director
Danderyds Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Denosumab in people with Osteolysis, run by Olof Skoldenberg at 1 site in Sweden.
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 8 inclusion and 32 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: status not confirmed, as of the sponsor's last update on 7 Feb 2019. 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 Sweden. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Volume of the osteolytic lesion (time frame: 3 years). 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 NCT02299817, which also lists 2 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 7 Feb 2019.