Postmenopausal OsteoporosisNCT04702204
Efficacy of Denosumab Treatment in Bisphosphonate Unresponsive Patients
An observational study of Postmenopausal Osteoporosis, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
This study, which was designed as a prospective observational study, was planned to enroll 75 female patients with postmenopausal osteoporosis who had been using bisphosphonates for more than two years and did not respond to treatment. 2 doses of denosumab were administered to the patients every 6 months. Read more about this study
- Who is it for?
- Ages 45 to 85 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- Denosumab 60 MG/ML
- Type of treatment
- Injection or infusion
- How many people
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2020to 15 Aug 2021
- Phase
- Observational
- 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 45 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This study, which was designed as a prospective observational study, was planned to enroll 75 female patients with postmenopausal osteoporosis who had been using bisphosphonates for more than two years and did not respond to treatment.
Who may be able to join
- Being a woman with postmenopausal osteoporosis
- Being between the ages of 45-85
- Using bisphosphonate therapy for at least two years
- Vertebral and/or Femur T score below -2.5
- Unresponsive to bisphosphonate therapy
- More than 2% decrease in BMD values despite using bisphosphonates and/or
- New major fracture development during treatment
Who cannot join
- Male gender
- Being extremely thin (BMI <15) or extremely obese (BMI> 45)
- Malignancy
- Severe chronic liver and kidney failure
- Chronic Steroid use
- Having an active rheumatic disease
- Having other secondary causes of osteoporosis (primary hyperparathyroidism etc.).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Niğde Bor FTR Education and Training hospital
Niğde, 51000
About this study
Official title: Efficacy and Safety of Denosumab Treatment in Bisphosphonate Unresponsive Postmenopausal Osteoporotic
This study, which was designed as a prospective observational study, was planned to enroll 75 female patients with postmenopausal osteoporosis who had been using bisphosphonates for more than two years and did not respond to treatment. 2 doses of denosumab were administered to the patients every 6 months. Bone mineral density of patients were measured with DEXA at the beginning and end of the study. A total of 66 patients completed the study.
At the end of the study, there was a significant improvement in the femur and lumbar total bone mineral density of the patients compared to the baseline. However, no statistically significant difference was found in terms of the frequency of new fractures.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Denosumab 60 MG/ML
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denosumab 60 MG/MLDrug
Denosumab, another antiresorptive agent, is a fully human monoclonal IgG2 antibody that binds to the receptor activator of the nuclear factor-kB ligand (RANKL) with high specificity and affinity. Denosumab inhibits bone resorption by affecting the development, activation, and survival of osteoclasts.
Denosumab 60 mg subcutaneously was administered to the patients whose consent forms were obtained, once every 6 months.
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
Femur and spine bone mineral density measurements of the patients at the baseline and the 12th month were performed using the Dual Energy X-ray Absorptiometry (DEXA) machine (Stratos dR 2D Fan-Beam, DMS company, France).
Measured: 12 month
Secondary outcomes (1)
Major Bone Fracture
number of newly developed vertebral and femur fractures during follow-up
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 Jul 2020
- Primary completion15 Aug 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal OsteoporosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ercan KAYDOK, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702204
- Sponsor's protocol ID
- 123
- Status last verified
- Aug 2021
- First submitted
- 3 Jan 2021
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
13. Miller PD, Pannacciulli N, Malouf-Sierra J, Singer A, Czerwiński E, Bone HG, et al. Efficacy and safety of denosumab vs. bisphosphonates in postmenopausal women previously treated with oral bisphosphonates. Osteoporos Int. 2020;31(1):181-91. 14. Kamimura M, Nakamura Y, Ikegami S, Uchiyama S, Kato H, Taguchi A. Significant improvement of bone mineral density and bone turnover markers by denosumab therapy in bisphosphonate-unresponsive patients. Osteoporos Int. 2017;28(2):559-66. 15. Roux C, Hofbauer LC, Ho PR, Wark JD, Zillikens MC, Fahrleitner-Pammer A, et al. Denosumab compared with risedronate in postmenopausal women suboptimally adherent to alendronate therapy: efficacy and safety results from a randomized open-label study. Bone. 2014;58:48-54 16. von Keyserlingk C, Hopkins R, Anastasilakis A, Toulis K, Goeree R, Tarride JE, et al. Clinical efficacy and safety of denosumab in postmenopausal women with low bone mineral density and osteoporosis: a meta-analysis. Semin Arthritis Rheum. 2011;41(2):178-86.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Denosumab Treatment in Bisphosphonate Unresponsive Postmenopausal Osteoporotic
- ClinicalTrials.gov ID
- NCT04702204
- Acronym / sponsor ID
- 123
- Conditions
- Postmenopausal Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 8 Jan 2021 (actual)
- 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 study, which was designed as a prospective observational study, was planned to enroll 75 female patients with postmenopausal osteoporosis who had been using bisphosphonates for more than two years and did not respond to treatment. 2 doses of denosumab were administered to the patients every 6 months. Bone mineral density of patients were measured with DEXA at the beginning and end of the study. A total of 66 patients completed the study.
At the end of the study, there was a significant improvement in the femur and lumbar total bone mineral density of the patients compared to the baseline. However, no statistically significant difference was found in terms of the frequency of new fractures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study, which was designed as a prospective observational study, was planned to enroll 75 female patients with postmenopausal osteoporosis who had been using bisphosphonates for more than two years and did not respond to treatment.
Key inclusion criteria (7 listed)
- Being a woman with postmenopausal osteoporosis
- Being between the ages of 45-85
- Using bisphosphonate therapy for at least two years
- Vertebral and/or Femur T score below -2.5
- Unresponsive to bisphosphonate therapy
Key exclusion criteria (7 listed)
- Male gender
- Being extremely thin (BMI <15) or extremely obese (BMI> 45)
- Malignancy
- Severe chronic liver and kidney failure
- Chronic Steroid use
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 |
|---|---|---|
| Denosumab 60 MG/MLDenosumab, another antiresorptive agent, is a fully human monoclonal IgG2 antibody that binds to the receptor activator of the nuclear factor-kB ligand (RANKL) with high specificity and affinity. Denosumab inhibits bone resorption by affecting the development, activation, and survival of osteoclasts. Denosumab 60 mg subcutaneously was administered to the patients whose consent forms were obtained, once every 6 months. | Drug | – |
Primary outcome
Bone mineral density
Time frame: 12 month
Femur and spine bone mineral density measurements of the patients at the baseline and the 12th month were performed using the Dual Energy X-ray Absorptiometry (DEXA) machine (Stratos dR 2D Fan-Beam, DMS company, France).
1 secondary outcome
Major Bone Fracture
Time frame: 12 month
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 1 Sep 2021.
- Background13. Miller PD, Pannacciulli N, Malouf-Sierra J, Singer A, Czerwiński E, Bone HG, et al. Efficacy and safety of denosumab vs. bisphosphonates in postmenopausal women previously treated with oral bisphosphonates. Osteoporos Int. 2020;31(1):181-91. 14. Kamimura M, Nakamura Y, Ikegami S, Uchiyama S, Kato H, Taguchi A. Significant improvement of bone mineral density and bone turnover markers by denosumab therapy in bisphosphonate-unresponsive patients. Osteoporos Int. 2017;28(2):559-66. 15. Roux C, Hofbauer LC, Ho PR, Wark JD, Zillikens MC, Fahrleitner-Pammer A, et al. Denosumab compared with risedronate in postmenopausal women suboptimally adherent to alendronate therapy: efficacy and safety results from a randomized open-label study. Bone. 2014;58:48-54 16. von Keyserlingk C, Hopkins R, Anastasilakis A, Toulis K, Goeree R, Tarride JE, et al. Clinical efficacy and safety of denosumab in postmenopausal women with low bone mineral density and osteoporosis: a meta-analysis. Semin Arthritis Rheum. 2011;41(2):178-86.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postmenopausal Osteoporosis, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
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 7 inclusion and 7 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 1 Sep 2021. 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 Turkey (Türkiye). 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 month). 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 NCT04702204, which also lists 1 linked publication.
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 1 Sep 2021.