Skip to main content
OpenTrials
Completed

NCT Number: NCT00372099

Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postmenopause

Age range

45 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Salmon Calcitonin

Drug

nasal salmon calcitonin 200UI/day during 2 years

Primary outcomes

  1. Bone micro-architecture evaluated by high resolution p-QCT

    Time frame: 24 months

Secondary outcomes

  1. Bone turn-over markers

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Rene Rizzoli

Other

Registry information

Official study 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)

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Sep 6, 2006
Registry last updated
Dec 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.