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

NCT ID: NCT00500409

Last Updated: 2014-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-07-31

Brief Summary

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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

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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.

Conditions

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Osteoporosis

Keywords

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rhPTH(1-34) Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drug Group

Osteoform

Group Type EXPERIMENTAL

Osteoform

Intervention Type DRUG

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

Control group

SHELCAL

Group Type ACTIVE_COMPARATOR

SHELCAL

Intervention Type DRUG

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

Interventions

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Osteoform

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

Intervention Type DRUG

SHELCAL

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

Intervention Type DRUG

Other Intervention Names

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Calcium and vitamin D

Eligibility Criteria

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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

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

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Virchow Group

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Bipin Kumar Sethi, MD, DM

Role: PRINCIPAL_INVESTIGATOR

CARE Hospitals, Hyderabad, AP, India

Dr. Manoj Chadha, MD, DM

Role: PRINCIPAL_INVESTIGATOR

P.D. Hinduja Hospital and Medical Research Centre, Mumbai, India

Dr. K.Prasanna Kumar, MD, DM

Role: PRINCIPAL_INVESTIGATOR

M.S. Ramaiah Medical College, Bangalore, India

Dr. K.D. Modi, MD, DM

Role: PRINCIPAL_INVESTIGATOR

Medwin Hospital, Hyderabad, AP, India

Dr. Rabinderanath Mehrotra, MD, DM

Role: PRINCIPAL_INVESTIGATOR

Apollo Hospitals, Hyderabad, AP, India

Dr. Usha Sriram, MD, DM

Role: PRINCIPAL_INVESTIGATOR

Apollo Hospitals, Chennai, India

Locations

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Apollo Hospitals

Hyderabaad, Andhra Pradesh, India

Site Status

CARE Hospitals

Hyderabaad, Andhra Pradesh, India

Site Status

Medwin Hospital

Hyderabaad, Andhra Pradesh, India

Site Status

MS Ramaiah Medical College

Bangalore, Karnataka, India

Site Status

P.D. Hinduja Hospital and Medical Research Center

Mumbai, Maharashtra, India

Site Status

Apollo Hospitals

Chennai, Tamil Nadu, India

Site Status

Countries

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India

References

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Sethi BK, Chadha M, Modi KD, Kumar KM, Mehrotra R, Sriram U. Efficacy of teriparatide in increasing bone mineral density in postmenopausal women with osteoporosis--an Indian experience. J Assoc Physicians India. 2008 Jun;56:418-24.

Reference Type DERIVED
PMID: 18822620 (View on PubMed)

Other Identifiers

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VB006/05

Identifier Type: -

Identifier Source: org_study_id