STUDY OF CIRCULATING OSTEOBLAST-LINEAGE CELLS IN RELATION WITH TERIPARATIDE THERAPY. - TERIPARATIDE

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-002958-29-IT

Enrollment

Registered

2006-08-30

Start date

2006-08-02

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

post-menopausal osteoporosis MedDRA version: 6.1 Level: PT Classification code 10031285

Interventions

Trade Name: FORSTEO*20MCG/80MCL 1PENNA Pharmaceutical Form: Solution for injection INN or Proposed INN: Teriparatide Concentration unit: µg microgram(s) Concentration type: equal Concentration number

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a. all patients will have a bone mineral density BMD T-score value of -2.5 S.D. or less according to the WHO criteria WHO Technical Report Series nr 843 Assessment of fracture risk and the application to screening for postmenopausal osteoporosis , 1994 . With or without fractures b. All subjects will be after at least 1 year of spontaneous menopause Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: a. Mentally or legal incapacity to give the informed consent b. presence of secondary osteoporosis c. absumption of calcium and vitamin D, thyroid hormones, corticosteroids, estrogen, bisphosphonates, parathyroid hormone, fluoride, strontium ranelate, and raloxifene in the previous six months. d. Treatment with an immunosupressant e.g. cyclosporine, azathyoprine within the previous year e. Hypersensitivity or serious adverse experience with raloxifene, teriparatide or calcium and vitamin D f. Hystory of cancer

Design outcomes

Primary

Measure	Time frame
Main Objective: to better elucidate the bone forming mechanism of teriparatide as regards the effect on osteoblast formation and differentiation ex vivo and in vitro;Secondary Objective: NOT APPLICABLE;Primary end point(s): to better elucidate the bone forming mechanism of teriparatide as regards the effect on osteoblast formation and differentiation ex vivo and in vitro	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026