Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00372099

Enrollment

Registered

2006-09-06

Start date

2007-01-31

Completion date

2011-11-30

Last updated

2011-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopause

Keywords

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

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.

Interventions

DRUGSalmon calcitonin

nasal salmon calcitonin 200UI/day during 2 years

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Bone micro-architecture evaluated by high resolution p-QCT	24 months

Secondary

Measure	Time frame
Bone turn-over markers	24 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026