NCT01224717

Brief Summary

This study is designed to provide information about the bone-anabolic response of PTH134 when administered orally, in comparison to Forsteo®, the sub-cutaneous form of teriparatide, the active ingredient in PTH134.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P75+ for phase_1

Geographic Reach
2 countries

4 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

September 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 20, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Last Updated

May 13, 2011

Status Verified

May 1, 2011

Enrollment Period

7 months

First QC Date

October 18, 2010

Last Update Submit

May 12, 2011

Conditions

Post-menopausal Osteoporosis

Keywords

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Measure: Effects of treatment on bone biomarkers. Measure levels of PINP, CTX-1, and serum calcium levels, serum phosphate, P1CP, bone-specific alkaline phosphatase, osteocalcin.

    12 weeks

Secondary Outcomes (1)

  • Change from baseline in serum calcium levels after 12 weeks of treatment

    12 weeks

Study Arms (3)

PTH134

EXPERIMENTAL
Drug: PTH134

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Forsteo

ACTIVE COMPARATOR
Drug: Forsteo

Interventions

PTH134DRUG
PTH134
PlaceboDRUG
Placebo
ForsteoDRUG
Forsteo

Eligibility Criteria

Age45 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Post-menopausal women osteoporotic/osteopenic with an additional risk factor 45 to 80 years old

You may not qualify if:

  • Use of estrogen or hormone replacement therapy
  • Use of parathormone or parathormone fragments, calcitonin, aluminum supplements, within 12 months prior to first dose.
  • Use of bisphosphonates and strontium ranelate
  • Cancer or history of malignancy of any organ system
  • Any radiation therapy to the skeleton.
  • Any known clinically significant disease affecting calcium metabolism. Any history of metabolic disorders including Paget's disease, osteogenesis imperfecta, or osteomalacia.
  • History or clinical evidence of any impairment of thyroid function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Novartis Investigative Site

Aalborg, Denmark

Location

Novartis Investigative Site

Ballerup Municipality, Denmark

Location

Novartis Investigative Site

Berlin, Germany

Location

Novartis Investigative Site

Munich, Germany

Location

MeSH Terms

Conditions

Osteoporosis, PostmenopausalOsteoporosis

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 18, 2010

First Posted

October 20, 2010

Study Start

September 1, 2010

Primary Completion

April 1, 2011

Last Updated

May 13, 2011

Record last verified: 2011-05

Locations

DE(2)DK(2)