Phase 3 Clinical Trial of Teriparatide in Japan

NCT00433160 | Completed Phase 3 Results

• 2 other identifiers: 10494B3D-JE-GHDB
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 16

Brief Summary

To evaluate the efficacy of teriparatide based on measurements of bone mineral density at lumbar spine

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)

  Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.

  Baseline to 52 weeks

Secondary Outcomes (19)

• Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)

  Baseline to 52 Weeks

• Percent Change in Bone Mineral Density (BMD) at Total Hip

  Baseline to 52 Weeks

• Percent Change in Bone Mineral Density (BMD) at Femoral Neck

  Baseline to 52 Weeks

• Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)

  Baseline to Weeks 4, 12, 24, and 52

• Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)

  Baseline to Weeks 4, 12, 24, 52

Study Arms (2)

Teriparatide

EXPERIMENTAL

20 micrograms for 104 weeks

Drug: Teriparatide

Placebo

PLACEBO COMPARATOR

Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks

Drug: Teriparatide; Drug: Placebo

Interventions

Teriparatide DRUG

daily, subcutaneous

Also known as: LY333334, Forteo, Forsteo

Placebo; Teriparatide

Placebo DRUG

daily, subcutaneous

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Japanese patients diagnosed with osteoporosis
• Aged 55 or older
• Patients who are at high risk for fracture

You may not qualify if:

• History of metabolic bone disorders other than primary osteoporosis
• History of malignant neoplasm in the 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated.
• Severe or chronically disabling conditions other than osteoporosis

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (16)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Aichi, 454-0933, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Fukuoka, 811-2101, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Hokkaido, 070-0034, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Hyōgo, 655-0853, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Kagoshima, 890-0014, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Kanagawa, 231-0023, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Nagano, 386-0493, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Nagasaki, 854-0083, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Numakunai, 020-8505, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Osaka, 555-0032, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Ōita, 879-7125, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Saitama, 358-0007, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Shimane, 693-0021, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Tokushima, 770-8503, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Tokyo, 163-0202, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Tottori, 683-0853, Japan

Location

Related Publications (2)

• Miyauchi A, Matsumoto T, Sugimoto T, Tsujimoto M, Warner MR, Nakamura T. Effects of teriparatide on bone mineral density and bone turnover markers in Japanese subjects with osteoporosis at high risk of fracture in a 24-month clinical study: 12-month, randomized, placebo-controlled, double-blind and 12-month open-label phases. Bone. 2010 Sep;47(3):493-502. doi: 10.1016/j.bone.2010.05.022. Epub 2010 May 24.

  PMID: 20580870 RESULT

• Yamamoto T, Tsujimoto M, Sowa H. Safety of daily teriparatide treatment: a post hoc analysis of a Phase III study to investigate the possible association of teriparatide treatment with calcium homeostasis in patients with serum procollagen type I N-terminal propeptide elevation. Clin Interv Aging. 2015 Jul 6;10:1101-9. doi: 10.2147/CIA.S83549. eCollection 2015.

  PMID: 26185429 DERIVED

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Osteoporosis

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; 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

Limitations and Caveats

Original data presented were for the 52-week double-blinded treatment phase; results of the open label phases at 76 weeks and 104 weeks have now been added

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• 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 7, 2007
• First Posted: February 9, 2007
• Study Start: January 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2009
• Last Updated: September 21, 2010
• Results First Posted: September 30, 2009

Record last verified: 2010-09

Locations

JP (16)