NCT00500409

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2005

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2007

Completed
Last Updated

December 16, 2014

Status Verified

July 1, 2007

Enrollment Period

1 year

First QC Date

July 11, 2007

Last Update Submit

December 15, 2014

Conditions

Osteoporosis

Keywords

rhPTH(1-34)Osteoporosis

Outcome Measures

Primary Outcomes (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.

    6 and 12 months

Secondary Outcomes (1)

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

    3, 6 and 12 months

Study Arms (2)

Drug Group

EXPERIMENTAL

Osteoform

Drug: Osteoform

Control group

ACTIVE COMPARATOR

SHELCAL

Drug: SHELCAL

Interventions

OsteoformDRUG

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

Drug Group
SHELCALDRUG

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

Also known as: Calcium and vitamin D
Control group

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Apollo Hospitals

Hyderabaad, Andhra Pradesh, India

Location

CARE Hospitals

Hyderabaad, Andhra Pradesh, India

Location

Medwin Hospital

Hyderabaad, Andhra Pradesh, India

Location

MS Ramaiah Medical College

Bangalore, Karnataka, India

Location

P.D. Hinduja Hospital and Medical Research Center

Mumbai, Maharashtra, India

Location

Apollo Hospitals

Chennai, Tamil Nadu, India

Location

Related Publications (1)

  • 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.

    PMID: 18822620DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

CalciumVitamin D

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2007

First Posted

July 12, 2007

Study Start

December 1, 2005

Primary Completion

December 1, 2006

Study Completion

July 1, 2007

Last Updated

December 16, 2014

Record last verified: 2007-07

Locations

IN(6)