Teriparatide Treatment in Patients With Inherited Osteoporosis

Osteoporosis Clinical Trial

Official title:

Efficacy of Teriparatide Treatment in Patients With New Forms of Inherited Low-Turnover Osteoporosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360424
• Other study ID #: HUS-LTO-PTH
• Secondary ID: 2010-019297-32
• Status: Completed
• Phase: Phase 4
• First received: May 6, 2011
• Last updated: September 27, 2015
• Start date: May 2011
• Est. completion date: November 2013

Study information

• Verified date: September 2015
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics CommitteeFinland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to analyse efficacy of teriparatide treatment in patients with new forms of inherited low-turnover osteoporosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• inherited low-turnover osteoporosis

• lumbar spine or hip BMD T-score = -2.5

• a written informed consent.

Exclusion Criteria:

• age less than 18 years

• generally accepted contraindications for the treatment

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Teriparatide
Daily administration of teriparatide 20 ug s.c. for 24 months

Locations

Country	Name	City	State
Finland	Department of Orthopaedics and Traumatology and Division of Endocrinology, Department of Medicine and Pediatric Endocrinology, Hospital for Children and Adolescents, Helsinki University Central Hospital	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Eli Lilly and Company

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in lumbar bone mineral density (BMD)	The primary outcome measure is the change in lumbar BMD measured with dual-energy X-ray absorptiometry (DXA) during the 24 months treatment period.	0, 12 and 24 months	No
Secondary	Change from baseline in whole body bone mineral density (DXA)		0,12 and 24 months	No
Secondary	Change from baseline in hip bone mineral density (DXA)		0,12 and 24 months	No
Secondary	Change from baseline in histomorphometry of bone biopsy samples	includes e.g following parameters: Bone volume (BV/TV, %); Osteoid volume (OV/BV, %); Trabecular thickness (Tb.Th, um); Osteoid surface (OS/BS, %); Osteoblast surface (Ob.S/BS, %); Eroded surface (ES/BS, %); Osteoclast surface (Oc.S/BS, %); Mineral apposition rate (MAR, um/day); Mineralizing surface (MS/BS, %)	0 and 24 months	No
Secondary	Change from baseline in bone microarchitecture assessed by micro computed tomography of bone biopsy samples	includes e.g following parameters: bone volume (BV, mm3); relative bone volume (BV/TV, %); connectivity density, (Conn.D., 1/mm3); trabecular number (DT-Tb.N, 1/mm); trabecular thickness (DT-Tb.Th, mm)	0 and 24 months	No
Secondary	Change from baseline in peripheral quantitative computed tomography (pQCT) measured cortical and trabecular volumetric bone mineral density of tibia and radius		0,12 and 24 months	No
Secondary	Number of vertebral fractures (spine X-ray)		24 months	No
Secondary	Change from baseline in serum procollagen type I N-terminal propeptide (PINP)		0,3,6,12 and 24 months	No
Secondary	Change from baseline in serum type I collagen C-telopeptides (CTX)		0,3,6,12 and 24 months	No
Secondary	Change from baseline in serum osteocalcin		0,3,6,12 and 24 months	No