OsteoporosisNIH fractureNCT02155595
Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy
An observational study of Osteoporosis and Atypical Femoral Fractures, run by Henry Ford Health System at 1 site in United States.
Trial summary
The purpose of this protocol is to determine the risk of atypical femoral shaft (thigh bone) fractures after long term fracture prevention therapy with a class of drugs called "bisphosphonates", colloquially referred to as Alendronate, risedronate, Ibandronate, and Zoledronate. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Osteoporosis, Atypical Femoral Fractures, Prodromal Bone Deterioration
- What is being tested?
- 500 without BP treatment and 500 with BP treatment
- How many people
- 738 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 31 Aug 2018
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be found within the Henry Ford Health System Division of Endocrinology, Diabetes, Bone \& Mineral Disorders
Who may be able to join
- women with a diagnosis of osteopenia or osteoporosis as defined by Bone Mineral density (BMD)
- patient treated with BPs for >5 years
- patients treated with non-BP anti-fracture medications such as...
- estrogens, raloxifene, calcitonin
- treatment naive patients
Who cannot join
- all men regardless of BMD result
- patients with obvious traumatic AFF
- patients with normal BMD (better than -1.0 T-score at spine or proximal hip)
- unable to take tetracycline
- previous use of teriparatide
- known allergies to the following:
Show all 9Show fewer
- tetracycline antibiotics
- meperidine
- midazolam
Trial locations and contacts
1 site in 1 country.
United States1 site
Henry Ford Medical Center, New Center One
Detroit, Michigan, 48202
About this study
The purpose of this protocol is to determine the risk of atypical femoral shaft (thigh bone) fractures after long term fracture prevention therapy with a class of drugs called "bisphosphonates", colloquially referred to as Alendronate, risedronate, Ibandronate, and Zoledronate.
In addition, the study is designed to find out which patient is most likely to develop this potential life changing complication and why. Finally, the results of this study will help clinicians to better understand the reason and thus tailor patient specific treatments…i.e., "the right treatment for the right patient for right duration."
- Being tested
- 500 without BP treatment, 500 with BP treatment
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
500 without BP treatmentOther
lab tests, X-ray, bone scan or MRI, as needed
500 with BP treatmentOther
lab tests, X-ray, bone scan or MRI, as needed (90 of these individuals can opt for iliac crest bone biopsy)
| Study group | Role | What they receive |
|---|---|---|
| 500 with BP treatment | patients will undergo lab tests, X-ray, bone scan or MRI, as needed (90 of these individuals can opt for iliac crest bone biopsy) Receives: Other: 500 with BP treatment | |
| 500 without BP treatment | patients will undergo lab tests, X-ray, bone scan or MRI, as needed Receives: Other: 500 without BP treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prodromal bone deterioration (PBD)
Determine the prevalence of PBD and/or Atypical Femoral Fractures (AFF) in patients with post-menopausal or glucocorticoid related osteoporosis, either treated with bisphosphonate (BP) for more than 2 years or never treated with a BP
Measured: 5 years
Secondary outcomes (1)
Diagnosis of PBD
Refine diagnostic criteria for the diagnosis of PBD
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startMay 2014
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
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 OsteoporosisStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 738 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Sudhaker D Rao, MD, Henry Ford Health System
- Investigators
- Sudhaker D. Rao, M.B;B.S., Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155595
- Sponsor's protocol ID
- 1R01AR062103-01A1
- Acronym
- NIH fracture
- Status last verified
- Mar 2019
- First submitted
- 29 Jan 2014
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Farlay D, Rizzo S, Ste-Marie LG, Michou L, Morin SN, Qiu S, Chavassieux P, Chapurlat RD, Rao SD, Brown JP, Boivin G. Duration-Dependent Increase of Human Bone Matrix Mineralization in Long-Term Bisphosphonate Users with Atypical Femur Fracture. J Bone Miner Res. 2021 Jun;36(6):1031-1041. doi: 10.1002/jbmr.4244. Epub 2021 Feb 11.
PubMed 33434290
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy
- ClinicalTrials.gov ID
- NCT02155595
- Acronym / sponsor ID
- NIH fracture / 1R01AR062103-01A1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 738 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- May 2014
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 4 Jun 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 purpose of this protocol is to determine the risk of atypical femoral shaft (thigh bone) fractures after long term fracture prevention therapy with a class of drugs called "bisphosphonates", colloquially referred to as Alendronate, risedronate, Ibandronate, and Zoledronate.
In addition, the study is designed to find out which patient is most likely to develop this potential life changing complication and why. Finally, the results of this study will help clinicians to better understand the reason and thus tailor patient specific treatments…i.e., "the right treatment for the right patient for right duration."
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 500 with BP treatment | – | Other: 500 with BP treatmentpatients will undergo lab tests, X-ray, bone scan or MRI, as needed (90 of these individuals can opt for iliac crest bone biopsy) |
| 500 without BP treatment | – | Other: 500 without BP treatmentpatients will undergo lab tests, X-ray, bone scan or MRI, as needed |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be found within the Henry Ford Health System Division of Endocrinology, Diabetes, Bone \& Mineral Disorders
Key inclusion criteria (5 listed)
- women with a diagnosis of osteopenia or osteoporosis as defined by Bone Mineral density (BMD)
- patient treated with BPs for >5 years
- patients treated with non-BP anti-fracture medications such as...
- estrogens, raloxifene, calcitonin
- treatment naive patients
Key exclusion criteria (9 listed)
- all men regardless of BMD result
- patients with obvious traumatic AFF
- patients with normal BMD (better than -1.0 T-score at spine or proximal hip)
- unable to take tetracycline
- previous use of teriparatide
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 |
|---|---|---|
| 500 without BP treatmentlab tests, X-ray, bone scan or MRI, as needed | Other | 500 without BP treatment |
| 500 with BP treatmentlab tests, X-ray, bone scan or MRI, as needed (90 of these individuals can opt for iliac crest bone biopsy) | Other | 500 with BP treatment |
Primary outcome
Prodromal bone deterioration (PBD)
Time frame: 5 years
Determine the prevalence of PBD and/or Atypical Femoral Fractures (AFF) in patients with post-menopausal or glucocorticoid related osteoporosis, either treated with bisphosphonate (BP) for more than 2 years or never treated with a BP
1 secondary outcome
Diagnosis of PBD
Time frame: 5 years
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 29 Mar 2019.
- Derived from this study: PubMed 33434290Farlay D, Rizzo S, Ste-Marie LG, Michou L, Morin SN, Qiu S, Chavassieux P, Chapurlat RD, Rao SD, Brown JP, Boivin G. Duration-Dependent Increase of Human Bone Matrix Mineralization in Long-Term Bisphosphonate Users with Atypical Femur Fracture. J Bone Miner Res. 2021 Jun;36(6):1031-1041. doi: 10.1002/jbmr.4244. Epub 2021 Feb 11.
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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.
Sudhaker D. Rao, M.B;B.S. principal investigator
Henry Ford Health System
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 Osteoporosis and Atypical Femoral Fractures, run by Henry Ford Health System at 1 site 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 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 29 Mar 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 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.
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?
Prodromal bone deterioration (PBD) (time frame: 5 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 NCT02155595, 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 29 Mar 2019.