Study to Evaluate Effect of Intranasal Teriparatide on Bone Mineral Density in Postmenopausal Women With Low BMD

March 11, 2008 updated by: Nastech Pharmaceutical Company, Inc.

A Phase 2, 24-Week, Multicenter, Randomized, Parallel-Group, Dose-Ranging Study To Evaluate The Effect Of Teriparatide Nasal Spray On Bone Mineral Density In Postmenopausal Women With Low Bone Mineral Density

This study is being conducted to compare the effect of increasing nasal teriparatide dosing on percent change in Bone Mineral Density (BMD) of the lumbar spine after 24 weeks of therapy in postmenopausal women with low bone mineral density.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Postmenopausal Female patients up to 89 years, inclusive;
  • BMI ≤ 35 kg/m2, inclusive;
  • In good health, determined by medical history and physical examination, as well as normal 12-lead ECG and vital signs;
  • Females will be non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile (including tubal ligation, hysterectomy) for at least 3 months, until 30 days following Study Completion be willing to use an approved method of contraception;
  • Have a minimum of two evaluable non-fractured lumbar vertebrae.
  • Have low bone mineral density defined as having a T-score ≤ -2.0 as determined by DXA scan at either the lumbar spine (L1-L4) or total hip

Exclusion Criteria:

  • Serious Medical Condition
  • History of diseases which affect bone metabolism other than postmenopausal osteoporosis such as Paget's disease, any secondary causes of osteoporosis, hypoparathyroidism, or hyperparathyroidism
  • Have a history of cancer within the past 5 years, except for basal cell carcinoma
  • Have hypocalcemia or hypercalcemia from any cause or have a recent history of kidney stones or pre-existing hypercalciuria;
  • Have used any of the mostly commonly prescribed osteoporosis medications within 3 months of starting the investigational product, or for more than 1 month at any time within 6 months prior to starting investigational product.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Drug: Teriparatide Nasal Spray
teriparatide intranasally daily for 24 weeks
Experimental: 3
Drug: Teriparatide Nasal Spray
teriparatide intranasally daily for 24 weeks
Experimental: 4
Drug: Teriparatide Nasal Spray
teriparatide intranasally daily for 24 weeks
Active Comparator: 1
Drug: Teriparatide
20ug subcutaneous injection daily for 24 weeks
Other Names:
  • Forteo
Experimental: 5
Drug: Teriparatide Nasal Spray
teriparatide intranasally daily for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in bone mineral density of the lumbar spine from baseline to 24 weeks post treatment.
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in bone mineral density from baseline to 12 weeks post treatment
Time Frame: 12 weeks
12 weeks
Safety, including hypercalcemia and nasal effects
Time Frame: 24 weeks
24 weeks
Change from baseline in bone markers PINP and CTX from baseline to 4, 12 and 24 weeks post treatment
Time Frame: 4, 12 and 24 weeks
4, 12 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nastech Pharmaceutical Company, Inc.

Investigators

  • Study Director: Gordon Brandt, MD, Nastech Pharmaceutical Company, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Anticipated)

April 1, 2009

Study Completion (Anticipated)

April 1, 2009

Study Registration Dates

First Submitted

February 19, 2008

First Submitted That Met QC Criteria

February 26, 2008

First Posted (Estimate)

February 27, 2008

Study Record Updates

Last Update Posted (Estimate)

March 13, 2008

Last Update Submitted That Met QC Criteria

March 11, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C07-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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