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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00624481
• Other study ID #: C07-008
• Status: Withdrawn
• Phase: Phase 2
• First received: February 19, 2008
• Last updated: March 11, 2008
• Start date: March 2008
• Est. completion date: April 2009

Study information

• Verified date: March 2008
• Source: Nastech Pharmaceutical Company, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 350
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 89 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Osteopenia
• Osteoporosis

Intervention

Drug:
• Teriparatide
20ug subcutaneous injection daily for 24 weeks
• Teriparatide Nasal Spray
teriparatide intranasally daily for 24 weeks
• Teriparatide Nasal Spray
teriparatide intranasally daily for 24 weeks
• Teriparatide Nasal Spray
teriparatide intranasally daily for 24 weeks
• Teriparatide Nasal Spray
teriparatide intranasally daily for 24 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nastech Pharmaceutical Company, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bone mineral density of the lumbar spine from baseline to 24 weeks post treatment.		24 weeks	No
Secondary	Change in bone mineral density from baseline to 12 weeks post treatment		12 weeks	No
Secondary	Safety, including hypercalcemia and nasal effects		24 weeks	Yes
Secondary	Change from baseline in bone markers PINP and CTX from baseline to 4, 12 and 24 weeks post treatment		4, 12 and 24 weeks	No