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Safety and Efficacy of OSTEOFORM (rhPTH [1-34]) in Increasing Bone Mineral Density in Osteoporosis

Primary Purpose

Osteoporosis

Status

Completed

Phase

Phase 3

Locations

India

Study Type

Interventional

Intervention

Osteoform

SHELCAL

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring rhPTH(1-34), Osteoporosis

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Postmenopausal women with osteoporosis (Lumbar spine or femoral neck BMD or total hip T-score less than or equal to-2.5)

Exclusion Criteria:

Women with vertebral (L1-L4) abnormalities that preclude accurate measurement by DEXA.
Women on medications that are known to affect bone for more than 7 days in the past 6 months.
Currently taking systemic prednisone, inhaled steroids, anticoagulants, anticonvulsants.
History of rhPTH use or known hypersensitivity to study drug.
Vitamin D3 deficiency (Vitamin D3 < 20 ng/ml).
Abnormal thyroid function.
History of kidney disease.
Any history of hypercalciuria, hypercalcemia or hyperparathyroidism.
History of active or treated tuberculosis or significant liver disease or gastrointestinal disease or cancer.

Sites / Locations

Apollo Hospitals
CARE Hospitals
Medwin Hospital
MS Ramaiah Medical College
P.D. Hinduja Hospital and Medical Research Center
Apollo Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Drug Group

Control group

Arm Description

Osteoform

SHELCAL

Outcomes

Primary Outcome Measures

Percentage of change in Bone Mineral Density at lumber spine (L1-L4) in postmenopausal women with osteoporosis at the end of 6 and 12 months.

Secondary Outcome Measures

Percentage of change from baseline in biomarkers of bone formation and bone resorption at the end of 3, 6 and 12 months.

Full Information

NCT ID

NCT00500409

First Posted

July 11, 2007

Last Updated

December 15, 2014

Sponsor

Virchow Group

1. Study Identification

Unique Protocol Identification Number

NCT00500409

Brief Title

Safety and Efficacy of OSTEOFORM (rhPTH [1-34]) in Increasing Bone Mineral Density in Osteoporosis

Official Title

Safety and Efficacy of OSTEOFORM (rhPTH [1-34]) in Increasing Bone Mineral Density in Osteoporosis. A Randomized Controlled Open-label Multicentre Study in India

Study Type

Interventional

2. Study Status

Record Verification Date

July 2007

Overall Recruitment Status

Completed

Study Start Date

December 2005 (undefined)

Primary Completion Date

December 2006 (Actual)

Study Completion Date

July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Virchow Group

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

OSTEOFORM, containing recombinant (rhPTH [1-34]), enhances bone mineral density and reduces risk for vertebral fracture. This study evaluates the safety and efficacy of OSTEOFORM in the treatment of osteoporosis in post-menopausal women.

Detailed Description

207 post-menopausal women were enrolled for screening at 6 centres, and supplemented with daily 1000 mg elemental calcium and 500 IU of vitamin D for 45 days. 82 eligible women with osteoporosis were randomly received daily either calcium and vitamin D alone (control group) or Osteoform 20 µg subcutaneously with calcium and vitamin D (drug group) for 12 months. End points such as percentage of increase in bone mineral density and, changes in bone biomarkers (serum osteocalcin, bone specific alkaline phosphatase, and urinary DPD) were evaluated at baseline, and 6 and 12 months after supplementation. Besides, safety parameters and adverse events were monitored through out the study period.

6. Conditions and Keywords

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

Osteoporosis

Keywords

rhPTH(1-34), Osteoporosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Drug Group

Arm Type

Experimental

Arm Description

Osteoform

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

SHELCAL

Intervention Type

Drug

Intervention Name(s)

Osteoform

Intervention Description

Administer Osteoform 20 µg daily subcutaneously and 1000 mg calcium and 500 IU vitamin D orally for 180 days

Intervention Type

Drug

Intervention Name(s)

SHELCAL

Other Intervention Name(s)

Calcium and vitamin D

Intervention Description

Administer calcium and vitamin D (1000 mg calcium and 500 IU vitamin D) orally for 180 days

Primary Outcome Measure Information:

Title

Percentage of change in Bone Mineral Density at lumber spine (L1-L4) in postmenopausal women with osteoporosis at the end of 6 and 12 months.

Time Frame

6 and 12 months

Secondary Outcome Measure Information:

Title

Percentage of change from baseline in biomarkers of bone formation and bone resorption at the end of 3, 6 and 12 months.

Time Frame

3, 6 and 12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Postmenopausal women with osteoporosis (Lumbar spine or femoral neck BMD or total hip T-score less than or equal to-2.5) Exclusion Criteria: Women with vertebral (L1-L4) abnormalities that preclude accurate measurement by DEXA. Women on medications that are known to affect bone for more than 7 days in the past 6 months. Currently taking systemic prednisone, inhaled steroids, anticoagulants, anticonvulsants. History of rhPTH use or known hypersensitivity to study drug. Vitamin D3 deficiency (Vitamin D3 < 20 ng/ml). Abnormal thyroid function. History of kidney disease. Any history of hypercalciuria, hypercalcemia or hyperparathyroidism. History of active or treated tuberculosis or significant liver disease or gastrointestinal disease or cancer.

Overall Study Officials: