OsteoporosisPhase 4NCT02576652
Bone Histomorphometry in Postmenopausal Men and Women With Osteoarthritis Undergoing Total Hip Replacement
A Phase 4 study testing Tetracycline, Demeclocycline and Total Hip Replacement in people with Osteoporosis, run by Amgen at 2 sites in United States.
Trial summary
The primary objective of this study is to determine the incidence of modeling-based bone formation in the femoral neck in participants who have received denosumab and are undergoing total hip replacement (THR). Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Tetracycline, Demeclocycline and Total Hip Replacement
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Dec 2015to 18 Dec 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has provided informed consent/assent prior to initiation of any study-specific activities/procedures
- Ambulatory postmenopausal women and men with osteoporosis
- Scheduled to undergo elective THR due to osteoarthritis of the hip
- Received at least 2 doses of denosumab 60 mg subcutaneously over 18 months
- Last dose of denosumab within 6 months of scheduled THR
Who cannot join
- Received treatment for osteoporosis other than denosumab in one year prior to THR
- Subjects with current diagnosis of any of the following conditions are excluded
- Current, uncontrolled hypo- or hyperthyroidism (subjects who have controlled hypo- or hyperthyroidism may be eligible, provided that they have been on a stable therapy for at least 3 months [per subject report])
- Current, hypo- or hyperparathyroidism
- Osteomalacia
- Paget's disease of bone
Show all 15Show fewer
- Other bone diseases which affect bone metabolism (eg, osteopetrosis, osteogenesis imperfecta)
- Severe chronic kidney disease (CKD), defined as CKD stage 4 or greater
- Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma)
- Self-reported alcohol or drug abuse within the previous 12 months
- Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s)
- Other investigational procedures while participating in this study are excluded
- Subject has known sensitivity to any of the products to be administered (eg, tetracycline, demeclocycline) during study
- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge
- History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Helen Hayes Hospital
West Haverstraw, New York, 10993
Research Site
West Haverstraw, New York, 10993
About this study
Official title: Bone Histomorphometry of the Proximal Femur in Denosumab-treated Subjects Undergoing Total Hip Replacement
The primary objective of this study is to determine the incidence of modeling-based bone formation in the femoral neck in participants who have received denosumab and are undergoing total hip replacement (THR).
- Conditions
- Osteoporosis
- Being tested
- Tetracycline, Demeclocycline, Total Hip Replacement
- Keywords
- bone biopsy, tetracycline, demeclocycline, total hip replacement
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetracyclineOther
Treatment during cycle 1 consists of a total oral dose of 1000 mg of tetracycline daily for a total of 3 days.
DemeclocyclineOther
Treatment during cycle 2 consists of a total oral dose of 600 mg of demeclocycline daily for 3 days.
Total Hip ReplacementProcedure or surgery
Participants entering this study were prescheduled to undergo elective THR due to osteoarthritis. Surgery was to be performed according to local standard of care. During THR a fragment of femoral bone was acquired for histomorphometry evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Osteoarthritis Participants | Other | Participants previously treated with denosumab and planning to undergo total hip replacement (THR) received one cycle of tetracycline administered at either 250 mg four times a day or 500 mg twice a day for 3 days and one cycle of demeclocycline administered at either 150 mg four times a day or 300 mg twice a day for 3 days, ten days after last dose of tetracycline in cycle 1. THR surgery was performed 5 to 42 days after the last dose of demeclocycline. Receives: Other: Tetracycline; Other: Demeclocycline; Procedure: Total Hip Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Modeling Based Bone Formation in the Femoral Neck
Femoral neck bone samples were prepared according to standard procedures for bone histology and bone histomorphometry at a central bone histomorphometry facility.
Modeling based formation units in active bone-forming, tetracycline-labeled surfaces were identified by a smooth cement line.
The percentage of participants with fluorochrome labeling present in the cancellous or periosteal, or endocortical surfaces of the femoral neck indicative of modeling-based bone formation is reported.
Measured: Days 22-58 (at the time of hip replacement surgery)
Secondary outcomes (3)
Modeling Based Formation Units in the Femoral Neck
Femoral neck bone samples were prepared according to standard procedures for bone histology and bone histomorphometry at a central bone histomorphometry facility.
Modeling based formation units in active bone-forming, tetracycline-labeled surfaces were identified by a smooth cement line. The number of modeling based formation units was evaluated at the cancellous, periosteal, and endocortical regions and is reported in units per mm of bone surface.
Measured: Days 22-58 (at the time of hip replacement surgery)
Overfilled Remodeling-based Formation Units in the Femoral Neck
Femoral neck bone samples were prepared according to standard procedures for bone histology and bone histomorphometry at a central bone histomorphometry facility.
Remodeling-based formation units in active bone-forming, tetracycline-labeled surfaces were identified by a scalloped cement line. The number of overfilled remodeling-based formation units was evaluated at the cancellous, periosteal, and endocortical regions and is reported as units per mm of bone surface.
Measured: Days 22-58 (at the time of hip replacement surgery)
Remodeling-based Formation Units Including Overfilled Units in the Femoral Neck
Femoral neck bone samples were prepared according to standard procedures for bone histology and bone histomorphometry at a central bone histomorphometry facility.
Remodeling based formation units in active bone-forming, tetracycline-labeled surfaces were identified by a scalloped cement line. The number of remodeling based formation units including overfilled units was evaluated at the cancellous, periosteal, and endocortical regions and is reported in units per mm of bone surface.
Measured: Days 22-58 (at the time of hip replacement surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study start22 Dec 2015
- Primary completion18 Dec 2017
- Study completion18 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576652
- Sponsor's protocol ID
- 20140259
- Status last verified
- Apr 2019
- First submitted
- 26 May 2015
- Last updated
- 26 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dempster DW, Chines A, Bostrom MP, Nieves JW, Zhou H, Chen L, Pannacciulli N, Wagman RB, Cosman F. Modeling-Based Bone Formation in the Human Femoral Neck in Subjects Treated With Denosumab. J Bone Miner Res. 2020 Jul;35(7):1282-1288. doi: 10.1002/jbmr.4006. Epub 2020 Apr 2.
PubMed 32163613
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Histomorphometry of the Proximal Femur in Denosumab-treated Subjects Undergoing Total Hip Replacement
- ClinicalTrials.gov ID
- NCT02576652
- Acronym / sponsor ID
- 20140259
- Conditions
- Osteoporosis
- Keywords
- bone biopsy, tetracycline, demeclocycline, total hip replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2015 (actual)
- Primary completion
- 18 Dec 2017 (actual)
- Study completion
- 18 Dec 2017 (actual)
- First posted
- 15 Oct 2015 (estimated)
- Results
- Posted 26 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine the incidence of modeling-based bone formation in the femoral neck in participants who have received denosumab and are undergoing total hip replacement (THR).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteoarthritis Participants | Other | Other: Tetracycline, Other: Demeclocycline, Procedure: Total Hip ReplacementParticipants previously treated with denosumab and planning to undergo total hip replacement (THR) received one cycle of tetracycline administered at either 250 mg four times a day or 500 mg twice a day for 3 days and one cycle of demeclocycline administered at either 150 mg four times a day or 300 mg twice a day for 3 days, ten days after last dose of tetracycline in cycle 1. THR surgery was performed 5 to 42 days after the last dose of demeclocycline. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has provided informed consent/assent prior to initiation of any study-specific activities/procedures
- Ambulatory postmenopausal women and men with osteoporosis
- Scheduled to undergo elective THR due to osteoarthritis of the hip
- Received at least 2 doses of denosumab 60 mg subcutaneously over 18 months
- Last dose of denosumab within 6 months of scheduled THR
Key exclusion criteria (15 listed)
- Received treatment for osteoporosis other than denosumab in one year prior to THR
- Subjects with current diagnosis of any of the following conditions are excluded
- Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma)
- Self-reported alcohol or drug abuse within the previous 12 months
- Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s)
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 |
|---|---|---|
| TetracyclineTreatment during cycle 1 consists of a total oral dose of 1000 mg of tetracycline daily for a total of 3 days. | Other | Osteoarthritis Participants |
| DemeclocyclineTreatment during cycle 2 consists of a total oral dose of 600 mg of demeclocycline daily for 3 days. | Other | Osteoarthritis Participants |
| Total Hip ReplacementParticipants entering this study were prescheduled to undergo elective THR due to osteoarthritis. Surgery was to be performed according to local standard of care. During THR a fragment of femoral bone was acquired for histomorphometry evaluation. | Procedure or surgery | Osteoarthritis Participants |
Primary outcome
Percentage of Participants With Modeling Based Bone Formation in the Femoral Neck
Time frame: Days 22-58 (at the time of hip replacement surgery)
Femoral neck bone samples were prepared according to standard procedures for bone histology and bone histomorphometry at a central bone histomorphometry facility. Modeling based formation units in active bone-forming, tetracycline-labeled surfaces were identified by a smooth cement line. The percentage of participants with fluorochrome labeling present in the cancellous or periosteal, or endocortical surfaces of the femoral neck indicative of modeling-based bone formation is reported.
3 secondary outcomes
Modeling Based Formation Units in the Femoral Neck
Time frame: Days 22-58 (at the time of hip replacement surgery)
Overfilled Remodeling-based Formation Units in the Femoral Neck
Time frame: Days 22-58 (at the time of hip replacement surgery)
Remodeling-based Formation Units Including Overfilled Units in the Femoral Neck
Time frame: Days 22-58 (at the time of hip replacement surgery)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32163613Dempster DW, Chines A, Bostrom MP, Nieves JW, Zhou H, Chen L, Pannacciulli N, Wagman RB, Cosman F. Modeling-Based Bone Formation in the Human Femoral Neck in Subjects Treated With Denosumab. J Bone Miner Res. 2020 Jul;35(7):1282-1288. doi: 10.1002/jbmr.4006. Epub 2020 Apr 2.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tetracycline, Demeclocycline and Total Hip Replacement in people with Osteoporosis, run by Amgen at 2 sites in United States.
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 5 inclusion and 15 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 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
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?
Yes. Results are posted in the registry (first posted 26 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Modeling Based Bone Formation in the Femoral Neck (time frame: Days 22-58 (at the time of hip replacement surgery)). 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 NCT02576652, 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 26 Apr 2019.