Clinical trial NCT00372099: Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopause
Keywords: Postmenopausal women
bone microarchitecture
peripheral quantitative micro-CT
salmon calcitonin
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2006-09-06
Enrollment: 90
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Bone micro-architecture evaluated by high resolution p-QCT
timeFrame: 24 months
Secondary outcomes:
measure: Bone turn-over markers
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Department of Rehabilitation and Geriatrics, University Hospital of Geneva
name: René Rizzoli, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.