Alendronate-Controlled Study in Postmenopausal Women with Osteoporosis Previously Treated with Romosozumab Followed by Alendronate Sequential Therapy

Phase 1

• Conditions: Postmenopausal osteoporosis; MedDRA version: 19.1Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2017-000675-90-CZ
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-12
• Last Update Posted: 17 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Subject has provided informed consent/assent prior to initiation of any study
specific activities/procedures.
OR
• Subject’s legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.
• Females who were initially randomized to the romosozumab to ALN sequential
treatment arm of the ARCH study and
- who have completed the Month 36 visit of the ARCH study
- who did not discontinue investigational product during the ARCH study and therein received at least 75% of planned romosozumab and ALN dosing
• Subject meets the following BMD criteria
- Subject has a DXA BMD T-score = -2.0 at the total hip or femoral neck (at or within 4 weeks of the start of screening), as assessed by imaging vendor.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

Disease Related
• Subjects with a positively adjudicated osteonecrosis of the jaw (ONJ) or atypical femoral fracture (AFF) event in the ARCH study or any history of ONJ or AFF events.
• Vitamin D insufficiency (defined as 25 (OH) vitamin D levels < 20 ng/mL as determined by the central laboratory). Vitamin D repletion and retesting within the screening window will be permitted.
• Current, uncontrolled hyper- or hypothyroidism. Uncontrolled hyperthyroidism is defined as thyroid-stimulating hormone (TSH) and thyroxine (T4) outside the normal range. Uncontrolled hypothyroidism is defined as TSH > 10.
• Current, uncontrolled hyperparathyroidism or history of hypoparathyroidism, per subject report or chart review. Uncontrolled hyperparathyroidism is defined as:
PTH outside the normal range in subjects with concurrent hypercalcemia; or PTH values > 20% above the upper limit of normal (ULN) in normocalcemic subjects.
• Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range, as assessed by the central laboratory.
Albumin-adjusted serum calcium levels may be retested once in case of an elevated albumin-adjusted serum calcium level within 1.1 x the ULN as assessed by the central laboratory.
• History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as sclerosteosis, Paget’s disease.
Other Medical Conditions
• Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years from the start of this study.
• Possible diagnosis of multiple myeloma or related lymphoproliferative disorder, as assessed by serum protein electrophoresis performed by the local laboratory (electrophoresis results within 6 months of signing consent will be acceptable).
• Positive for Hepatitis B.
• Positive for Hepatitis C, Chronic Hepatitis C, and negative viral load while receiving treatment for Hepatitis C.
• Positive results for Human Immunodeficiency Virus (HIV) or known to be HIV-positive
Prior/Concomitant Therapy
• Subjects who have stopped taking ALN for > 3 months since ending the ARCH study and prior to enrollment in this study.
• Use of strontium ranelate, or fluoride (for osteoporosis): more than 1 month of cumulative use within 5 years prior to randomization for, during, or after completion of the ARCH study.
• Use of Intravenous (IV) bisphosphonates.
- Zoledronic acid:
o any dose received within 3 years prior to randomization for, during, or after completion of the ARCH study
o more than 1 dose received within 5 years prior to randomization for, during, or after completion of the ARCH study
- IV ibandronate or IV pamidronate:
o any dose received within 12 months prior to randomization for, during, or after completion of the ARCH study
o more than 3 years of cumulative use, unless last dose received = 5 years prior to randomization for the ARCH study
o Use of oral bisphosphonates:
- any dose received within 3 months prior to randomization for, during, or after completion of the ARCH study
- more than 1 month of cumulative use between 3 and 12 months prior to randomization for, during, or after completion of the ARCH study
- more than 3 years of cumulative use, unless last dose received = 5 years prior to randomization for the ARCH study
• Use of denosumab or any cathepsin K inhibitor, such as odanacatib (MK-0822): any dose received within 18 mont

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified