PROPOSE Quality - PReOtact in Postmenopausal OStEoporosis - Quality of Life Study (FP-004-DE)

NCT00515593 | Completed DMC

• 1 other identifier: FP-004-DE
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of the study are

• to describe the quality of life at the beginning of the Preotact® treatment and at the end of the observational period (Qualeffo-41 questionnaire)
• pain assessment at the beginning of the Preotact® treatment and at the end of the observational period (VAS score)
• to describe bone mineral density at the beginning of the Preotact® treatment and at the end of the observational period (T-Score)
• to describe incidence of bone fractures caused by osteoporosis as well as of other pathological findings of the skeleton after the beginning of the Preotact® treatment
• to describe serum level of calcium and the bone resorption marker desoxypyridinoline (DPD) and N- respectively C-terminal crosslink-telopeptide (CTX and NTX) at the beginning of the Preotact® treatment and at the end of the observational period (only in subgroup of patients, where the physician sees a need to measure these parameters)
• to document all adverse drug reactions after the beginning of the Preotact® treatment
• the analysis of subgroups with different risk for bone fractures caused by osteoporosis at the beginning of the Preotact® treatment
• to assess the manageability and functioning of the Pen system for injection of Preotact® (self administered questionnaire)

Conditions

Postmenopause; Osteoporosis

Keywords

osteoporosis; postmenopausal women; Severe postmenopausal osteoporosis

Interventions

Parathyroid hormone (PTH) (Preotact) DRUG

Patients with severe postmenopausal osteoporosis

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe postmenopausal osteoporosis

You may qualify if:

• Caution should be taken by the treating Physician concerning any precautions, warnings and potential drug interactions stated in the SPC.

Sponsors & Collaborators

• Nycomed: lead

Study Sites (1)

Nycomed Deutschland GmbH

Cities in Germany, Germany

Location

Related Publications (1)

• Moricke R, Rettig K, Bethke TD. Use of recombinant human parathyroid hormone(1-84) in patients with postmenopausal osteoporosis: a prospective, open-label, single-arm, multicentre, observational cohort study of the effects of treatment on quality of life and pain--the PROPOSE study. Clin Drug Investig. 2011;31(2):87-99. doi: 10.2165/11538880-000000000-00000.

  PMID: 21155613 DERIVED

MeSH Terms

Conditions

Osteoporosis; Osteoporosis, Postmenopausal

Interventions

Parathyroid Hormone

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Nycomed Clinical Trial Operations

  Headquaters

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 13, 2007
• First Posted: August 14, 2007
• Study Start: September 1, 2006
• Study Completion: July 1, 2008
• Last Updated: May 7, 2012

Record last verified: 2012-05

Locations

DE (1)