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

Information source: Nastech Pharmaceutical Company, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteopenia; Osteoporosis

Intervention: Teriparatide (Drug); Teriparatide Nasal Spray (Drug); Teriparatide Nasal Spray (Drug); Teriparatide Nasal Spray (Drug); Teriparatide Nasal Spray (Drug)

Phase: Phase 2

Status: Withdrawn

Sponsored by: Nastech Pharmaceutical Company, Inc.

Official(s) and/or principal investigator(s):
Gordon Brandt, MD, Study Director, Affiliation: Nastech Pharmaceutical Company, Inc.

Summary

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in bone mineral density of the lumbar spine from baseline to 24 weeks post treatment.

Secondary outcome:

Change in bone mineral density from baseline to 12 weeks post treatment

Safety, including hypercalcemia and nasal effects

Change from baseline in bone markers PINP and CTX from baseline to 4, 12 and 24 weeks post treatment

Eligibility

Minimum age: N/A. Maximum age: 89 Years. Gender(s): Female.

Criteria:

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.

Locations and Contacts

Additional Information

Starting date: March 2008
Last updated: March 11, 2008

Page last updated: August 20, 2015

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