AGA2118 for Postmenopausal osteoporosis

Inclusion criteria

• {"criterion_text":"-Healthy, ambulatory, postmenopausal women age >=55 to <=80\n-BMD T-score of <=-2.5 to >-3.5 at the lumbar spine, total hip, or femoral neck"}

Exclusion criteria

• {"criterion_text":"-History of vertebral fracture, or fragility fracture of the wrist, humerus, proximal femur, or pelvis\n-Malignancy within the last 5 years\n-Use of agents affecting bone metabolism\n-Vitamin D deficiency\n-Known intolerance to calcium or vitamin D supplements\n-Untreated hyper- or hypothyroidism\n-Current hyper- or hypoparathyroidism\n-Elevated transaminases\n-Significantly impaired renal function\n-Current hypo- or hypercalcemia\n-Positive for HIV, hepatitis C virus, or hepatitis B surface antigen\n-Diagnosis of a familial cancer syndrome or known genetic mutation that increases risk of cancer\n-Myocardial infarction or stroke within the past 12 months"}

Primary endpoints

• {"endpoint_text":"-Percent change from Baseline to Month 12 in lumbar spine BMD","definition_or_measurement_approach":"Percent change from baseline to Month 12 in lumbar spine bone mineral density (BMD). Measurement approach indicated in study documentation: BMD assessed at skeletal sites (lumbar spine) using DEXA (DXA) imaging (Image Analysis Limited listed for DEXA and X-rays)."}

Secondary endpoints

• {"endpoint_text":"-Percent change from Baseline to Months 3 and 6 in lumbar spine, total hip, femoral neck, and one-third distal radius BMD","definition_or_measurement_approach":"Percent change from baseline to Months 3 and 6 in BMD at lumbar spine, total hip, femoral neck and one-third distal radius measured by DEXA (DXA) per study documents."}
• {"endpoint_text":"-Percent change from Baseline to Month 12 in total hip, femoral neck, and one-third distal radius BMD","definition_or_measurement_approach":"Percent change from baseline to Month 12 in BMD at total hip, femoral neck and one-third distal radius measured by DEXA (DXA)."}
• {"endpoint_text":"-Percent change from Baseline to Months 1, 3, 6, 9, and 12 in [CCI]","definition_or_measurement_approach":"Percent change from baseline at listed timepoints for the specified composite/clinical chemical indicator ([CCI]) as defined in study protocol. Specific measurement method for [CCI] not provided in the CTIS record."}
• {"endpoint_text":"-Incidence of new clinical fractures (vertebral and nonvertebral) between Baseline and Month 12","definition_or_measurement_approach":"Incidence of new clinical fractures (vertebral and nonvertebral) from baseline to Month 12 assessed by clinical assessment and imaging (X-rays/DEXA indicated in study support documents)."}

Methods

• Online advertisements / social media banners / online banners (documents: Poster_Social Media_Online_banner, Online Ad-Email Content) — country-targeted materials present in CTIS for Poland, Denmark, Estonia, Bulgaria.
• Landing page / website recruitment material (document: Landing Page_Public) — country-specific landing page materials included (associated documents for countries).
• Printed posters and leaflets (documents: Poster_Public, Leaflet_v1_Public, Leaflet_v2_Public) — used for local site/community recruitment.
• Recruitment brochures and patient letters (documents: Recruiting Brochure, Patient Letter) — country-specific brochure/letter materials for participants.
• Information for external doctors (document: Information for external Doctors_Public) — materials to engage referring clinicians.
• Advertisement posters (country-specific versions e.g., Danish advertisement poster) and local-language recruiting brochures (e.g., Estonian, Bulgarian, Polish) — country-targeted offline recruitment.
• Third-party vendor supported recruitment and advertising (Stark Raving LLC listed with duty 'Patient recruitment and advertising').

Bulgaria

Earliest CTIS Part Ii Submission Date

21-11-2024

Latest Decision Or Authorization Date

13-01-2025

Processing Time Days

53

Number Of Sites

2

Number Of Participants

25

Denmark

Earliest CTIS Part Ii Submission Date

19-12-2024

Latest Decision Or Authorization Date

10-01-2025

Processing Time Days

22

Number Of Sites

2

Number Of Participants

25

Estonia

Earliest CTIS Part Ii Submission Date

14-11-2024

Latest Decision Or Authorization Date

10-01-2025

Processing Time Days

57

Number Of Sites

3

Number Of Participants

25

Poland

Earliest CTIS Part Ii Submission Date

26-11-2024

Latest Decision Or Authorization Date

23-12-2025

Processing Time Days

392

Number Of Sites

6

Number Of Participants

185

Primary sponsor

Full Name

Angitia Inc. Ltd.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Worldwide Clinical Trials d.o.o.

Responsibilities

Multiple operational roles including DMC and legal representation (as listed in sponsor third-party duties).

Name

Triumph Research Intelligence Limited

Responsibilities

Risk management and central monitoring activities.

Third parties

• {"country":"United States","full_name":"Stark Raving LLC","duties_or_roles":"Patient recruitment and advertising","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Catalent Pharma Solutions LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient reimbursement","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Merative US LP","duties_or_roles":"CTMS","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United Kingdom","full_name":"Triumph Research Intelligence Limited","duties_or_roles":"Risk management and central monitoring activities","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Croatia","full_name":"Worldwide Clinical Trials d.o.o.","duties_or_roles":"Multiple operational roles incl. DMC, Legal representation","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Image Analysis Limited","duties_or_roles":"DEXA and X-rays","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Catalent Germany Schorndorf GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}