Clinical trial NCT00500409: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: rhPTH(1-34)
Osteoporosis
Lead sponsor: Virchow Group
Sponsor class: INDUSTRY
First posted: 2007-07-12
Enrollment: 82
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

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.

Primary outcomes:
measure: 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.
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Percentage of change from baseline in biomarkers of bone formation and bone resorption at the end of 3, 6 and 12 months.
timeFrame: 3, 6 and 12 months
Other outcomes:
Locations:
city: Hyderabaad
country: India
facility: Apollo Hospitals
state: Andhra Pradesh
city: Hyderabaad
country: India
facility: CARE Hospitals
state: Andhra Pradesh
city: Hyderabaad
country: India
facility: Medwin Hospital
state: Andhra Pradesh
city: Bangalore
country: India
facility: MS Ramaiah Medical College
state: Karnataka
city: Mumbai
country: India
facility: P.D. Hinduja Hospital and Medical Research Center
state: Maharastra
city: Chennai
country: India
facility: Apollo Hospitals
state: Tamil Nadu
Study officials:
affiliation: CARE Hospitals, Hyderabad, AP, India
name: Dr. Bipin Kumar Sethi, MD, DM
role: PRINCIPAL_INVESTIGATOR
affiliation: P.D. Hinduja Hospital and Medical Research Centre, Mumbai, India
name: Dr. Manoj Chadha, MD, DM
role: PRINCIPAL_INVESTIGATOR
affiliation: M.S. Ramaiah Medical College, Bangalore, India
name: Dr. K.Prasanna Kumar, MD, DM
role: PRINCIPAL_INVESTIGATOR
affiliation: Medwin Hospital, Hyderabad, AP, India
name: Dr. K.D. Modi, MD, DM
role: PRINCIPAL_INVESTIGATOR
affiliation: Apollo Hospitals, Hyderabad, AP, India
name: Dr. Rabinderanath Mehrotra, MD, DM
role: PRINCIPAL_INVESTIGATOR
affiliation: Apollo Hospitals, Chennai, India
name: Dr. Usha Sriram, MD, DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.