OsteoporosisCONTINUITYNCT01854086
Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday
An observational study of Osteoporosis, run by Meir Medical Center at 1 site in Israel.
Trial summary
The purpose of the study is to provide information about the rate of response and persistence to drug therapies for osteoporosis. Another issue examined in this study refers to the preferences and concerns about future treatments in patients during "drug holiday". Read more about this study
- Who is it for?
- Ages 40 to 90 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Questionnaires about compliance and persistence with bisphosphonates treatment
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2013to Feb 2014
- How long will I take part?
- 1 Day
- 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 40 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with osteoporosis,who been treated in Endocrinology Clinic of Medical Center
Who may be able to join
- Postmenopausal women
- Diagnosis of osteoporosis in the medical record
- At least one prescription drug to treat osteoporosis in the last 5 years
- Insured by "Clalit" Health Services
- Hebrew-speaking capability and readiness to answer a questionnaire
Who cannot join
- Premenopausal women
- No diagnosis of osteoporosis in the medical record
- No treatment for osteoporosis in the last 5 years
- Women who do not speak Hebrew or are unable to answer a questionnaire
Trial locations and contacts
1 site in 1 country.
Israel1 site
Meir medical center the clalit health care services group
Kfar Saba, 44281
Pnina Rotman, M.D, 972-57-7482609, Pnina.Rotman@clalit.org.il
Pnina Rotman, M.D
About this study
Official title: Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday: Data From a Single Outpatient Endocrine Clinic.
The purpose of the study is to provide information about the rate of response and persistence to drug therapies for osteoporosis. Another issue examined in this study refers to the preferences and concerns about future treatments in patients during "drug holiday".
- Conditions
- Osteoporosis
- Being tested
- Questionnaires about compliance and persistence with bisphosphonates treatment
- Keywords
- osteoporosis, postmenopausal, patient compliance, compliance, diphosphonates, bisphosphonates
- Medical subject headings
- Osteoporosis, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires about compliance and persistence with bisphosphonates treatmentOther
| Study group | Role | What they receive |
|---|---|---|
| Postmenopausal women | Postmenopausal women treated with bisphosphonates Receives: Other: Questionnaires about compliance and persistence with bisphosphonates treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance and persistence to osteoporosis drug therapy
Data collection will be done by questionnaires and from the medical record of the patient. The information collected will include: demographic information, measurements of bone density, additional information about the disease and treatment that the patient receives,prescription purchases and additional drugs the patient is taking (steroids, PPI's(Proton Pump Inhibitors) / H2 receptor antagonists and NSAIDs(Non Steroidal Anti Inflammatories)).
Measured: Participants will be followed for the duration of their clinic visit, an average of 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startSep 2013
- Primary completionFeb 2014 (estimated)
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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854086
- Sponsor's protocol ID
- MMC130009-13CTIL
- Acronym
- CONTINUITY
- Status last verified
- May 2013
- First submitted
- 6 May 2013
- Last updated
- 15 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Cramer JA, Amonkar MM, Hebborn A, Altman R. Compliance and persistence with bisphosphonate dosing regimens among women with postmenopausal osteoporosis. Curr Med Res Opin. 2005 Sep;21(9):1453-60. doi: 10.1185/030079905X61875.
PubMed 16197664
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday: Data From a Single Outpatient Endocrine Clinic.
- ClinicalTrials.gov ID
- NCT01854086
- Acronym / sponsor ID
- CONTINUITY / MMC130009-13CTIL
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, postmenopausal, patient compliance, compliance, diphosphonates, bisphosphonates
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Feb 2014 (estimated)
- First posted
- 15 May 2013 (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 the study is to provide information about the rate of response and persistence to drug therapies for osteoporosis. Another issue examined in this study refers to the preferences and concerns about future treatments in patients during "drug holiday".
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postmenopausal women | – | Other: Questionnaires about compliance and persistence with bisphosphonates treatmentPostmenopausal women treated with bisphosphonates |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with osteoporosis,who been treated in Endocrinology Clinic of Medical Center
Key inclusion criteria (5 listed)
- Postmenopausal women
- Diagnosis of osteoporosis in the medical record
- At least one prescription drug to treat osteoporosis in the last 5 years
- Insured by "Clalit" Health Services
- Hebrew-speaking capability and readiness to answer a questionnaire
Key exclusion criteria (4 listed)
- Premenopausal women
- No diagnosis of osteoporosis in the medical record
- No treatment for osteoporosis in the last 5 years
- Women who do not speak Hebrew or are unable to answer a questionnaire
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 |
|---|---|---|
| Questionnaires about compliance and persistence with bisphosphonates treatment | Other | Postmenopausal women |
Primary outcome
Compliance and persistence to osteoporosis drug therapy
Time frame: Participants will be followed for the duration of their clinic visit, an average of 5 hours
Data collection will be done by questionnaires and from the medical record of the patient. The information collected will include: demographic information, measurements of bone density, additional information about the disease and treatment that the patient receives,prescription purchases and additional drugs the patient is taking (steroids, PPI's(Proton Pump Inhibitors) / H2 receptor antagonists and NSAIDs(Non Steroidal Anti Inflammatories)).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2013.
- Results publication: PubMed 16197664Cramer JA, Amonkar MM, Hebborn A, Altman R. Compliance and persistence with bisphosphonate dosing regimens among women with postmenopausal osteoporosis. Curr Med Res Opin. 2005 Sep;21(9):1453-60. doi: 10.1185/030079905X61875.
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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.
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, run by Meir Medical Center at 1 site in Israel.
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 4 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 15 May 2013. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pnina Rotman, M.D (972-57-7482609, Pnina.Rotman@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance and persistence to osteoporosis drug therapy (time frame: Participants will be followed for the duration of their clinic visit, an average of 5 hours). 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 NCT01854086, 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 15 May 2013.