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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Nastech Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:
NCT00624481
First received: February 19, 2008
Last updated: March 11, 2008
Last verified: March 2008
  Purpose

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.


Condition Intervention Phase
Osteopenia
Osteoporosis
Drug: Teriparatide
Drug: Teriparatide Nasal Spray
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Nastech Pharmaceutical Company, Inc.:

Primary Outcome Measures:
  • Change in bone mineral density of the lumbar spine from baseline to 24 weeks post treatment. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in bone mineral density from baseline to 12 weeks post treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Safety, including hypercalcemia and nasal effects [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: March 2008
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Teriparatide
20ug subcutaneous injection daily for 24 weeks
Other Name: Forteo
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
Experimental: 5 Drug: Teriparatide Nasal Spray
teriparatide intranasally daily for 24 weeks

  Eligibility

Ages Eligible for Study:   up to 89 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00624481

Sponsors and Collaborators
Nastech Pharmaceutical Company, Inc.
Investigators
Study Director: Gordon Brandt, MD Nastech Pharmaceutical Company, Inc.
  More Information

No publications provided

Responsible Party: Nastech Pharmaceutical Company Inc. ( Gordon Brandt, M.D. / President ), Nastech Pharmaceutical Company Inc.
ClinicalTrials.gov Identifier: NCT00624481     History of Changes
Other Study ID Numbers: C07-008
Study First Received: February 19, 2008
Last Updated: March 11, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Nastech Pharmaceutical Company, Inc.:
osteoporosis
osteopenia
bone mineral density
teriparatide

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Osteoporosis
Bone Diseases
Musculoskeletal Diseases
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014