PostmenopausePhase 3NCT00372099
Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women
A Phase 3 study testing Salmon calcitonin in people with Postmenopause, run by Rene Rizzoli.
Trial summary
Calcitonin has been used for many years for treating osteoporosis in postmenopausal women. Recent data from the 2 years placebo-controlled QUEST study have shown a preservation of microarchitecture as measured by high resolution MRI in postmenopausal women with prevalent vertebral fractures at baseline.This pilot… Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopause
- What is being tested?
- Salmon calcitonin
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Nov 2011
- Phase
- Phase 3
- 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 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women between age 45-70
- Natural or surgical menopause ≥ 1 year
- T-Score between 0.0 and -2.49 (spine or proximal femur - total or femoral neck measured by DXA)
Who cannot join
- Osteoporosis (T-score ≤ -2.5 in spine or proximal femur - total or femoral neck, measured by DXA)
- Severe vertebral fracture, as identified by screening DXA assessment
- Any history of metabolic disease, which could affect bone metabolism: hyperparathyroidism, osteogenesis imperfecta, Paget's disease, osteomalacia
- Thyroid disease (if receiving thyroid hormone replacement, the patients must be euthyroid, and on a stable dose of thyroid hormone)
- Impaired renal function (estimated GFR<30 ml/min)
- History of previous or active malignancy of any organ system, treated or not treated within the past 5 years.
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- History of corticosteroids treatments during 6 months or more, daily dosage >5 mg .
- BMI < 18 or >30.
- Treatments with estrogens, SERMs, tibolone, calcitonin, strontium ranelate, teriparatide or PTH, oral or iv bisphosphonates in the previous year.
About this study
Official title: Evaluation of the Effects of Salmon Calcitonin Nasal Spray Compared to Placebo on Bone Microarchitecture Measured by High Resolution Peripheral Micro- Computed-tomography Over 2 Years in Postmenopausal Women (a Pilot Study)
Calcitonin has been used for many years for treating osteoporosis in postmenopausal women. Recent data from the 2 years placebo-controlled QUEST study have shown a preservation of microarchitecture as measured by high resolution MRI in postmenopausal women with prevalent vertebral fractures at baseline.This pilot study should provide additional new insights in the mode of action of nasal calcitonin, on structural changes as measured by high resolution peripheral CT, and on the comparison between weight bearing and non weight bearing bones in postmenopausal women.
- Conditions
- Postmenopause
- Being tested
- Salmon calcitonin
- Keywords
- Postmenopausal women, bone microarchitecture, peripheral quantitative micro-CT, salmon calcitonin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salmon calcitoninDrug
nasal salmon calcitonin 200UI/day during 2 years
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone micro-architecture evaluated by high resolution p-QCT
Measured: 24 months
Secondary outcomes (1)
Bone turn-over markers
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2006 (estimated)
- Study startJan 2007
- Primary completionOct 2011
- Study completionNov 2011
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 PostmenopauseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rene Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rene Rizzoli, University Hospital, Geneva
- Investigators
- René Rizzoli, Professor, Principal investigator, Department of Rehabilitation and Geriatrics, University Hospital of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372099
- Sponsor's protocol ID
- 05-262/Psy 05-038
- Other IDs
- CSMC051ACH01
- Status last verified
- Dec 2011
- First submitted
- 5 Sep 2006
- Last updated
- 23 Dec 2011
- Results posted
- No
Publications
Richert L, Uebelhart B, Engelhardt M, Azria M, Rizzoli R. A randomized double-blind placebo-controlled trial to investigate the effects of nasal calcitonin on bone microarchitecture measured by high-resolution peripheral quantitative computerized tomography in postmenopausal women - study protocol. Trials. 2008 Apr 13;9:19. doi: 10.1186/1745-6215-9-19.
PubMed 18405390
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Salmon Calcitonin Nasal Spray Compared to Placebo on Bone Microarchitecture Measured by High Resolution Peripheral Micro- Computed-tomography Over 2 Years in Postmenopausal Women (a Pilot Study)
- ClinicalTrials.gov ID
- NCT00372099
- Acronym / sponsor ID
- 05-262/Psy 05-038
- Conditions
- Postmenopause
- Keywords
- Postmenopausal women, bone microarchitecture, peripheral quantitative micro-CT, salmon calcitonin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Rene RizzoliUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 6 Sep 2006 (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.
Calcitonin has been used for many years for treating osteoporosis in postmenopausal women. Recent data from the 2 years placebo-controlled QUEST study have shown a preservation of microarchitecture as measured by high resolution MRI in postmenopausal women with prevalent vertebral fractures at baseline.This pilot study should provide additional new insights in the mode of action of nasal calcitonin, on structural changes as measured by high resolution peripheral CT, and on the comparison between weight bearing and non weight bearing bones in postmenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women between age 45-70
- Natural or surgical menopause ≥ 1 year
- T-Score between 0.0 and -2.49 (spine or proximal femur - total or femoral neck measured by DXA)
Key exclusion criteria (9 listed)
- Osteoporosis (T-score ≤ -2.5 in spine or proximal femur - total or femoral neck, measured by DXA)
- Severe vertebral fracture, as identified by screening DXA assessment
- Any history of metabolic disease, which could affect bone metabolism: hyperparathyroidism, osteogenesis imperfecta, Paget's disease, osteomalacia
- Thyroid disease (if receiving thyroid hormone replacement, the patients must be euthyroid, and on a stable dose of thyroid hormone)
- Impaired renal function (estimated GFR<30 ml/min)
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 |
|---|---|---|
| Salmon calcitoninnasal salmon calcitonin 200UI/day during 2 years | Drug | – |
Primary outcome
Bone micro-architecture evaluated by high resolution p-QCT
Time frame: 24 months
1 secondary outcome
Bone turn-over markers
Time frame: 24 months
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 23 Dec 2011.
- Derived from this study: PubMed 18405390Richert L, Uebelhart B, Engelhardt M, Azria M, Rizzoli R. A randomized double-blind placebo-controlled trial to investigate the effects of nasal calcitonin on bone microarchitecture measured by high-resolution peripheral quantitative computerized tomography in postmenopausal women - study protocol. Trials. 2008 Apr 13;9:19. doi: 10.1186/1745-6215-9-19.
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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.
René Rizzoli, Professor principal investigator
Department of Rehabilitation and Geriatrics, University Hospital of Geneva
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Salmon calcitonin in people with Postmenopause, run by Rene Rizzoli.
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 3 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 23 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 micro-architecture evaluated by high resolution p-QCT (time frame: 24 months). 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 NCT00372099, 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 23 Dec 2011.