NCT07028320

Brief Summary

To Evaluate the Efficacy and Safety of SAL056 for Postmenopausal Women with Osteoporosis at High Fracture Risk

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
493

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 19, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

2.1 years

First QC Date

June 11, 2025

Last Update Submit

June 19, 2025

Conditions

Postmenopausal Women With Osteoporosis

Keywords

Postmenopausal Women With Osteoporosis; Teriparatide

Outcome Measures

Primary Outcomes (1)

  • Percent Change in Bone Mineral Density (BMD) of Lumbar Spine from Baseline to 48 Weeks

    Percent Change in Bone Mineral Density (BMD) of Lumbar Spine from Baseline to 48 Weeks

    Baseline to 48 Weeks

Secondary Outcomes (4)

  • Percent Change in Bone Mineral Density (BMD) of Lumbar Spine from Baseline to 24 Weeks

    Baseline to 24 Weeks

  • Percent Change in Bone Mineral Density (BMD) of Total Hip from Baseline to 24/48 Weeks

    Baseline to 24/48 Weeks

  • Percent Change in S-CTX and P1NP From Baseline to12/ 24/48 Weeks

    Baseline to 12/24/48 Weeks

  • Proportion of Subjects with New Fragility Fractures from Baseline to 24/48 Week

    Baseline to 24/48 Weeks

Study Arms (2)

Drug: SAL056 (56.5μg)

EXPERIMENTAL

Administered by subcutaneous injection once a week during treatment phase

Drug: SAL056 (56.5μg)

Drug: Alendronate

ACTIVE COMPARATOR

70 mg tablet taken once a week during treatment phase

Drug: Alendronate

Interventions

SAL056 (56.5μg)DRUG

Administered by subcutaneous injection once a week during treatment phase

Also known as: Teriparatide for Injection
Drug: SAL056 (56.5μg)
AlendronateDRUG

70 mg tablet taken once a week during treatment phase

Drug: Alendronate

Eligibility Criteria

Age45 Years - 80 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women with the ability to live independently (≥45 and ≤80 years);
  • The patient has a body mass index(BMI) of 18.0 kg/m2 to 30 kg/m2； The patient has one of the following diagnostic criteria for osteoporosis and subject has at least 2 consecutive vertebrae region (L1 to L4) that are evaluable by dual-energy x-ray absorptiometry (DXA)，a) History of hip/vertebra fragility fracture and bone mineral density (BMD) T-score ≤-1; b）the axial bone (lumbar , femoral neck or total hip) mineral density (BMD) T-score ≤-2.50;c) Bone mineral density (BMD) T-score ≥-2.5 and ≤-1 with proximal humerus, pelvis, or distal forearm end fragility fracture

You may not qualify if:

  • In addition to postmenopausal osteoporosis, the other diseases affecting bone metabolism;
  • Patients with other diseases affecting calcium or bone metabolism;
  • Received anti-osteoporosis treatment that does not meet protocol requirements;
  • Received medication that affects bone metabolism prior to screening, or is planned to use prohibited drugs/non-drug therapy under the protocol during the study period;
  • Patients requiring long-term or continuous use of digoxin and other digitalis drugs during the trial;
  • Patients with other severe underlying diseases； Patients with abnormal indicators that does not meet protocol requirements during the screening periodlaboratory tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Sixth People's Hosptital

Shanghai, China

Location

MeSH Terms

Interventions

TeriparatideInjectionsAlendronate

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsDrug Administration RoutesDrug TherapyTherapeuticsDiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Zheng Lin Zhang

    Shanghai 6th People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2025

First Posted

June 19, 2025

Study Start

December 3, 2021

Primary Completion

December 30, 2023

Study Completion

May 20, 2024

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)