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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00624481
Recruitment Status : Withdrawn
First Posted : February 27, 2008
Last Update Posted : March 13, 2008
Information provided by:
Nastech Pharmaceutical Company, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Osteopenia Osteoporosis Drug: Teriparatide Drug: Teriparatide Nasal Spray Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2008
Estimated Primary Completion Date : April 2009
Estimated Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in bone mineral density of the lumbar spine from baseline to 24 weeks post treatment. [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Change in bone mineral density from baseline to 12 weeks post treatment [ Time Frame: 12 weeks ]
  2. Safety, including hypercalcemia and nasal effects [ Time Frame: 24 weeks ]
  3. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 89 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00624481

Sponsors and Collaborators
Nastech Pharmaceutical Company, Inc.
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Study Director: Gordon Brandt, MD Nastech Pharmaceutical Company, Inc.
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Responsible Party: Nastech Pharmaceutical Company Inc. ( Gordon Brandt, M.D. / President ), Nastech Pharmaceutical Company Inc. Identifier: NCT00624481    
Other Study ID Numbers: C07-008
First Posted: February 27, 2008    Key Record Dates
Last Update Posted: March 13, 2008
Last Verified: March 2008
Keywords provided by Nastech Pharmaceutical Company, Inc.:
bone mineral density
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents