Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women

NCT00372099 | Completed Phase 3

• 2 other identifiers: 05-262/Psy 05-038CSMC051ACH01
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postmenopause

Keywords

Postmenopausal women; bone microarchitecture; peripheral quantitative micro-CT; salmon calcitonin

Outcome Measures

Primary Outcomes (1)

• Bone micro-architecture evaluated by high resolution p-QCT

  24 months

Secondary Outcomes (1)

• Bone turn-over markers

  24 months

Interventions

Salmon calcitonin DRUG

nasal salmon calcitonin 200UI/day during 2 years

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rene Rizzoli: lead

Related Publications (1)

• 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.

  PMID: 18405390 DERIVED

MeSH Terms

Interventions

salmon calcitonin

Study Officials

• René Rizzoli, Professor

  Department of Rehabilitation and Geriatrics, University Hospital of Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 5, 2006
• First Posted: September 6, 2006
• Study Start: January 1, 2007
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 23, 2011

Record last verified: 2011-12