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

Sponsored by:	Virchow Group
Information provided by:	Virchow Group
ClinicalTrials.gov Identifier:	NCT00500409

Purpose

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.

Condition	Intervention	Phase
Osteoporosis	Drug: OSTEOFORM (rhPTH [1-34]) along with calcium and vitamin D	Phase III

MedlinePlus related topics: Minerals Osteoporosis

Drug Information available for: Calcium gluconate Vitamin D Ergocalciferol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Virchow Group:

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. [ Time Frame: 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. [ Time Frame: 3, 6 and 12 months ]

Enrollment:	82
Study Start Date:	December 2005
Study Completion Date:	July 2007

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.

Eligibility

Ages Eligible for Study:	45 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500409

Locations

India, Andhra Pradesh
CARE Hospitals
Hyderabaad, Andhra Pradesh, India
Medwin Hospital
Hyderabaad, Andhra Pradesh, India
Apollo Hospitals
Hyderabaad, Andhra Pradesh, India
India, Karnataka
MS Ramaiah Medical College
Bangalore, Karnataka, India
India, Maharastra
P.D. Hinduja Hospital and Medical Research Center
Mumbai, Maharastra, India
India, Tamil Nadu
Apollo Hospitals
Chennai, Tamil Nadu, India

Sponsors and Collaborators

Virchow Group

Investigators

Principal Investigator:	Dr. Bipin Kumar Sethi, MD, DM	CARE Hospitals, Hyderabad, AP, India
Principal Investigator:	Dr. Manoj Chadha, MD, DM	P.D. Hinduja Hospital and Medical Research Centre, Mumbai, India
Principal Investigator:	Dr. K.Prasanna Kumar, MD, DM	M.S. Ramaiah Medical College, Bangalore, India
Principal Investigator:	Dr. K.D. Modi, MD, DM	Medwin Hospital, Hyderabad, AP, India
Principal Investigator:	Dr. Rabinderanath Mehrotra, MD, DM	Apollo Hospitals, Hyderabad, AP, India
Principal Investigator:	Dr. Usha Sriram, MD, DM	Apollo Hospitals, Chennai, India

More Information

Publications indexed to this study:

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.

Study ID Numbers:	VB006/05
Study First Received:	July 11, 2007
Last Updated:	July 11, 2007
ClinicalTrials.gov Identifier:	NCT00500409
Health Authority:	India: Ministry of Health

Keywords provided by Virchow Group:

rhPTH(1-34)
Osteoporosis

Study placed in the following topic categories:

Calcium, Dietary
Vitamin D
Musculoskeletal Diseases
Ergocalciferols

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on January 14, 2009