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

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ClinicalTrials.gov Identifier: NCT00500409
Recruitment Status : Completed
First Posted : July 12, 2007
Last Update Posted : December 16, 2014
Sponsor:
Information provided by (Responsible Party):
Virchow Group

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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Osteoform Drug: SHELCAL Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Drug Group
Osteoform
Drug: Osteoform
Administer Osteoform 20 µg daily subcutaneously and 1000 mg calcium and 500 IU vitamin D orally for 180 days

Active Comparator: Control group
SHELCAL
Drug: SHELCAL
Administer calcium and vitamin D (1000 mg calcium and 500 IU vitamin D) orally for 180 days
Other Name: Calcium and vitamin D




Primary Outcome Measures :
  1. 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 :
  1. 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 ]


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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes 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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00500409


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Virchow Group
ClinicalTrials.gov Identifier: NCT00500409     History of Changes
Other Study ID Numbers: VB006/05
First Posted: July 12, 2007    Key Record Dates
Last Update Posted: December 16, 2014
Last Verified: July 2007

Keywords provided by Virchow Group:
rhPTH(1-34)
Osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamins
Vitamin D
Ergocalciferols
Calcium, Dietary
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents