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Osteoarthritis, HipPhase 2NCT01630941

Effects of Denosumab on Periprosthetic Bone After Total Hip Arthroplasty

A Phase 2 study testing denosumab in people with Osteoarthritis, Hip and Ambulation Difficulty, run by Hans Mallmin at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 65 years
Conditions the study is for
Osteoarthritis, Hip, Ambulation Difficulty
What is being tested?
denosumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
1 siteSweden
Study dates
7 Aug 2012to 30 Mar 2017
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 35 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • male or female patient 35-65 years of age with an unilateral OAH requiring a THA and a healthy contralateral hip
  • body weight ≤110 kg or body mass index (BMI) ≤35 kg/m2
  • living in the Uppsala County
  • the eligible patients should have been given oral information, a written Patient Information and signed an Informed Consent

Who cannot join

  • on or previously have had bone-specific treatment, e.g. bisphosphonates, raloxifene, parathyroid hormone, strontium ranelate, during the last five years
  • patients on systemical corticosteroid for more than 3 months should not be considered
  • patients with diagnosed malignant disease during the last five years or known to have metastasis from malignant disease should be excluded
  • patients with compromised general conditions and an American Society of Anesthesiologists, ASA-score >31 should not be regarded eligible
  • patients with known drug or alcohol abuse or regarded as socially dysfunctional, as judged by the investigator, should not be considered for the study
  • pregnant women or women planning for pregnancy or fertile women (premenopausal) without contraceptives should not be accepted for the study
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  • 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.
  • 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
  • any condition or laboratory findings which in the opinion of the Investigator makes the patient unsuitable for inclusion (for example claustrophobia)

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Department of Orthopedics

    Uppsala

Other trials in Sweden

About this study

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

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.

Read the detailed 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.

Being tested
denosumab
Keywords
Osteoarthritis of the hip, Uncemented Total Hip Arthroplasty, DXA, BMD, PET, CT, Biochemical bone markers
Medical subject headings
Osteoarthritis, Hip, Mobility Limitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • denosumabDrug

    Also called Prolia

    Two doses of 60 mg in a solution of 1 ml, given as an subcutaneous injection with a 6 month interval

Study groups in NCT01630941
Study groupRoleWhat they receive
DenosumabActive comparator1 ml (60 mg) subcutaneous injection Denosumab give in the posterior part of the upper arm after surgery followed by another injection 6 months later
Receives: Drug: denosumab
salinePlacebo comparator1 ml subcutaneous injection 0.9% saline give in the posterior part of the upper arm after surgery followed by another injection 6 months later
Receives: Drug: denosumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bone Mineral Density

    Bone mineral density by DXA in Gruen Zone 7 and a sum of Gruen zone 1-7

    Measured: 12 months

Secondary outcomes (11)

  1. Bone mineral Density

    BMD, g/cm2, adjacent to the femur implant for Gruen Zone 1-7, 3, 6, and 24 months after surgery

    Measured: 24 months

  2. Standardised Uptake value

    fluoride isotope uptake, measured as (SUV), adjacent to the femoral stem, 3 and 6 months after surgery.

    Measured: 6 months

  3. Standardised Uptake value

    fluoride isotope uptake, measured as SUV adjacent to the acetabular cup 3 and 6 months after surgery

    Measured: 6 months

  4. Bone Mineral density

    BMD adjacent to the acetabular cup during the follow up period, i.e. after 3, 6, 12 and 24 months

    Measured: 24 months

  5. Bone Mineral Density

    BMD at the lumbar spine and at the contra lateral nonoperated hip 6, 12 and 24 months after surgery

    Measured: 24 months

  6. Standardised Uptake Value

    Fluoride isotope uptake measured as SUV at the lumbar spine and at the contra lateral nonoperated hip after 3 and 6 months

    Measured: 6 months

  7. Biochemical markers for bone metabolism

    biochemical markers for bone turnover and the relation to SUV and BMD findings at the proximal femur and acetabulum during the follow up period, i.e. 3, 6, 12 and 24 months after surgery

    Measured: 24 months

  8. Biochemical markers for bone metabolism in relation to Bone Mineral Density and Standardised Uptake Value

    biochemical markers for bone turnover and the relation to SUV and BMD findings at anatomical sites not exposed to surgery, i.e. the lumbar spine and the contra lateral hip 3 and 6 months after surgery

    Measured: 24

  9. Biochemical markers for bone metabolism in relation to Bone Mineral Density and Standardised Uptake Value

    to evaluate the natural course of an uncemented THA on BMD, i.e. the placebo group 3, 6, 12 and 24 months after surgery, SUV i.e. the placebo group 3 and 6 months after surgery and on biochemical markers, i.e. the placebo group 3, 6, 12 and 24 months after surgery

    Measured: 24

  10. Clinical outcome evaluation

    to evaluate the patients Quality of Life, measured by Harris Hip score and EQ-5D questionnaires

    Measured: 24 months

  11. Adverse events

    incidence and severity of adverse events (AEs) during the study period

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2012 (estimated)
  2. Study start7 Aug 2012
  3. Primary completion16 Jan 2017
  4. Study completion30 Mar 2017

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01630941
Sponsor's protocol ID
2011-001481-18
Status last verified
Apr 2017
First submitted
26 Jun 2012
Last updated
5 Apr 2017
Results posted
No
Data monitoring committee
No

Publications

  • Skold C, Hailer NP, Mallmin H. Denosumab and bone loss in uncemented total hip arthroplasty: a secondary 5-year follow-up of a randomized controlled trial. Acta Orthop. 2026 Apr 1;97:217-224. doi: 10.2340/17453674.2026.45695.

    PubMed 41921101

  • Kultima K, Ashtiani SH, Erngren I, Khoonsari PE, Carlsson H, Herman S, Freyhult E, Mallmin H, Hailer NP. Uncemented hip arthroplasty and denosumab: increased postoperative dipeptide concentrations and identification of potential new bone turnover biomarkers. JBMR Plus. 2025 May 19;9(7):ziaf091. doi: 10.1093/jbmrpl/ziaf091. eCollection 2025 Jul.

    PubMed 40584156

  • Nystrom A, Kiritopoulos D, Ullmark G, Sorensen J, Petren-Mallmin M, Milbrink J, Hailer NP, Mallmin H. Denosumab Prevents Early Periprosthetic Bone Loss After Uncemented Total Hip Arthroplasty: Results from a Randomized Placebo-Controlled Clinical Trial. J Bone Miner Res. 2020 Feb;35(2):239-247. doi: 10.1002/jbmr.3883. Epub 2019 Nov 4.

    PubMed 31589776

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing denosumab in people with Osteoarthritis, Hip and Ambulation Difficulty, run by Hans Mallmin 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 4 inclusion and 9 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 5 Apr 2017. 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?

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?

Bone Mineral Density (time frame: 12 months). 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 NCT01630941, which also lists 3 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 5 Apr 2017.

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