OsteoporosisNCT00936260
Drug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis
A study testing alendronate in people with Osteoporosis, run by Ciudad Universitaria, Spain at 1 site in Spain.
Trial summary
The purpose of this study is to determine the duration of the treatment with alendronate in postmenopausal women with osteoporosis. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- alendronate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteSpain
- Study dates
- Jan 1998to Dec 2004
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- postmenopausal osteoporosis under densitometric criteria of the World Health Organization
Who cannot join
- secondary osteoporosis
- alteration in analytic parameters (total proteins, calcium, phosphorus, vitamin D, parathyroid hormone, thyroid hormone, transaminase, creatinine)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the duration of the treatment with alendronate in postmenopausal women with osteoporosis.
Read the detailed description
The duration of the treatment with alendronate is not well established. The investigators recruited 228 women with postmenopausal osteoporosis. They all received alendronate during the first 3 years of monitoring and were later on randomized to whether different regimens of intermittent treatment or to carry on 3 years more.
- Conditions
- Osteoporosis
- Being tested
- alendronate
- Keywords
- osteoporosis, postmenopausal, alendronate
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alendronateDrug
Also called fosamax
several duration of treatment
| Study group | Role | What they receive |
|---|---|---|
| alendronate 6 years | Experimental | Not described Receives: Drug: alendronate |
| alendronate 5 years | Experimental | No treatment during year 6th Receives: Drug: alendronate |
| alendronate 5 years, not continued | Experimental | No treatment during year 5th Receives: Drug: alendronate |
| alendronate 4 years | Experimental | No treatment during year 5th and 6th Receives: Drug: alendronate |
| alendronate 5 years, uncontinued | Experimental | No treatment during year 4th Receives: Drug: alendronate |
| alendronate 4 years, not continued | Experimental | No treatment during year 4th and 6th Receives: Drug: alendronate |
| alendronate 4 years, uncontinued | Experimental | No treatment during year 4th and 5th Receives: Drug: alendronate |
| Alendronato 3 years | Experimental | No treatment during the last 3 years Receives: Drug: alendronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
Measured: Every year
Secondary outcomes (1)
Fractures
Measured: Every year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startJan 1998
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciudad Universitaria, Spain
- Sponsor type
- University, hospital or other
- Investigators
- Carlos Lozano Tonkin, doctor, Study director, university san carlos hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936260
- Sponsor's protocol ID
- individual reseacher
- Status last verified
- Jan 1998
- First submitted
- 9 Jul 2009
- Last updated
- 10 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT00936260
- Acronym / sponsor ID
- individual reseacher
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, postmenopausal, alendronate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Ciudad Universitaria, SpainUniversity, hospital or other
- Study start
- Jan 1998
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 10 Jul 2009 (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 study is to determine the duration of the treatment with alendronate in postmenopausal women with osteoporosis.
Detailed description
The duration of the treatment with alendronate is not well established. The investigators recruited 228 women with postmenopausal osteoporosis. They all received alendronate during the first 3 years of monitoring and were later on randomized to whether different regimens of intermittent treatment or to carry on 3 years more.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| alendronate 6 years | Experimental | Drug: alendronate |
| alendronate 5 years | Experimental | Drug: alendronateNo treatment during year 6th |
| alendronate 5 years, not continued | Experimental | Drug: alendronateNo treatment during year 5th |
| alendronate 4 years | Experimental | Drug: alendronateNo treatment during year 5th and 6th |
| alendronate 5 years, uncontinued | Experimental | Drug: alendronateNo treatment during year 4th |
| alendronate 4 years, not continued | Experimental | Drug: alendronateNo treatment during year 4th and 6th |
| alendronate 4 years, uncontinued | Experimental | Drug: alendronateNo treatment during year 4th and 5th |
| Alendronato 3 years | Experimental | Drug: alendronateNo treatment during the last 3 years |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- postmenopausal osteoporosis under densitometric criteria of the World Health Organization
Key exclusion criteria (2 listed)
- secondary osteoporosis
- alteration in analytic parameters (total proteins, calcium, phosphorus, vitamin D, parathyroid hormone, thyroid hormone, transaminase, creatinine)
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 |
|---|---|---|
| alendronateAlso: fosamaxseveral duration of treatment | Drug | Alendronato 3 years, alendronate 4 years, alendronate 4 years, not continued, alendronate 4 years, uncontinued, alendronate 5 years, alendronate 5 years, not continued, alendronate 5 years, uncontinued, alendronate 6 years |
Primary outcome
Bone mineral density
Time frame: Every year
1 secondary outcome
Fractures
Time frame: Every year
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 10 Jul 2009.
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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.
Carlos Lozano Tonkin, doctor study director
university san carlos hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alendronate in people with Osteoporosis, run by Ciudad Universitaria, Spain at 1 site in Spain.
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 1 inclusion and 2 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 10 Jul 2009. 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 Spain. 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: Every year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2009.