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Teriparatide Treatment in Patients With Inherited Osteoporosis

Primary Purpose

Osteoporosis

Status

Completed

Phase

Phase 4

Locations

Finland

Study Type

Interventional

Intervention

Teriparatide

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring osteoporosis, teriparatide, bone turnover, New forms of inherited low-turnover osteoporosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Orthopaedics and Traumatology and Division of Endocrinology, Department of Medicine and Pediatric Endocrinology, Hospital for Children and Adolescents, Helsinki University Central Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

teriparatide

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from baseline in whole body bone mineral density (DXA)

Change from baseline in hip bone mineral density (DXA)

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, %)

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)

Change from baseline in peripheral quantitative computed tomography (pQCT) measured cortical and trabecular volumetric bone mineral density of tibia and radius

Number of vertebral fractures (spine X-ray)

Change from baseline in serum procollagen type I N-terminal propeptide (PINP)

Change from baseline in serum type I collagen C-telopeptides (CTX)

Change from baseline in serum osteocalcin

Full Information

NCT ID

NCT01360424

First Posted

May 6, 2011

Last Updated

September 27, 2015

Sponsor

Helsinki University Central Hospital

Collaborators

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01360424

Brief Title

Teriparatide Treatment in Patients With Inherited Osteoporosis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Helsinki University Central Hospital

Collaborators

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

Keywords

osteoporosis, teriparatide, bone turnover, New forms of inherited low-turnover osteoporosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

teriparatide

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Teriparatide

Intervention Description

Daily administration of teriparatide 20 ug s.c. for 24 months

Primary Outcome Measure Information:

Title

Change from baseline in lumbar bone mineral density (BMD)

Description

The primary outcome measure is the change in lumbar BMD measured with dual-energy X-ray absorptiometry (DXA) during the 24 months treatment period.

Time Frame

0, 12 and 24 months

Secondary Outcome Measure Information:

Title

Change from baseline in whole body bone mineral density (DXA)

Time Frame

0,12 and 24 months

Title

Change from baseline in hip bone mineral density (DXA)

Time Frame

0,12 and 24 months

Title

Change from baseline in histomorphometry of bone biopsy samples

Description

Time Frame

0 and 24 months

Title

Change from baseline in bone microarchitecture assessed by micro computed tomography of bone biopsy samples

Description

Time Frame

0 and 24 months

Title

Change from baseline in peripheral quantitative computed tomography (pQCT) measured cortical and trabecular volumetric bone mineral density of tibia and radius

Time Frame

0,12 and 24 months

Title

Number of vertebral fractures (spine X-ray)

Time Frame

24 months

Title

Change from baseline in serum procollagen type I N-terminal propeptide (PINP)

Time Frame

0,3,6,12 and 24 months

Title

Change from baseline in serum type I collagen C-telopeptides (CTX)

Time Frame

0,3,6,12 and 24 months

Title

Change from baseline in serum osteocalcin

Time Frame

0,3,6,12 and 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matti Välimäki, MD,PhD

Organizational Affiliation

Division of Endocrinology, Department of Medicine, Helsinki University Central Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Orthopaedics and Traumatology and Division of Endocrinology, Department of Medicine and Pediatric Endocrinology, Hospital for Children and Adolescents, Helsinki University Central Hospital

City

Helsinki

ZIP/Postal Code

FI-00029 HUS

Country

Finland

12. IPD Sharing Statement

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Teriparatide Treatment in Patients With Inherited Osteoporosis

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