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Phase 2 Dose-Finding Study of JTT-305 in Patients with Primary Osteoporosis.

Phase 2 Dose-Finding Study of JTT-305 in Patients with Primary Osteoporosis.

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220803
Enrollment
320
Registered
2009-08-14
Start date
2009-08-14
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Osteoporosis

Interventions

investigational material(s) Generic name etc : JTT-305 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigatio

Sponsors

JAPAN TABACCO INC.
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: - More than 5 years since menopause - < 70% of YAM at lumbar spine - < 80% of YAM at lumbar spine with one mild vertebral fracture

Exclusion criteria

Exclusion criteria: - Vertebral fractures on the 1st to 4th lumbar spine - History of drug use; 1) Strontium ranelate, anti-RANKL antibody preparations, or parathyroid hormone preparations 2) Bisphosphonates within 1 year of the screening visit

Design outcomes

Primary

MeasureTime frame
Percentile change in lumbar spine BMD

Secondary

MeasureTime frame
Bone turnover markers

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026