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

NCT00624481 | Withdrawn Phase 2

• 1 other identifier: C07-008
• Study Type: interventional
• Target: 350
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteopenia; Osteoporosis

Keywords

osteoporosis; osteopenia; bone mineral density; teriparatide

Outcome Measures

Primary Outcomes (1)

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

  24 weeks

Secondary Outcomes (3)

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

  12 weeks

• Safety, including hypercalcemia and nasal effects

  24 weeks

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

  4, 12 and 24 weeks

Study Arms (5)

1

ACTIVE COMPARATOR

Drug: Teriparatide

2

EXPERIMENTAL

Drug: Teriparatide Nasal Spray

3

EXPERIMENTAL

Drug: Teriparatide Nasal Spray

4

EXPERIMENTAL

Drug: Teriparatide Nasal Spray

5

EXPERIMENTAL

Drug: Teriparatide Nasal Spray

Interventions

Teriparatide DRUG

20ug subcutaneous injection daily for 24 weeks

Also known as: Forteo

1

Teriparatide Nasal Spray DRUG

teriparatide intranasally daily for 24 weeks

2

Eligibility Criteria

• Age: Up to 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nastech Pharmaceutical Company, Inc.: lead

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Gordon Brandt, MD

  Nastech Pharmaceutical Company, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 27, 2008
• Study Start: March 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: March 13, 2008

Record last verified: 2008-03