Current studies | UCB
UCB's Global Corporate Website

OP0002

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women with Osteoporosis

Brief summary

The purpose of the study is to evaluate the effect of treatment with romosozumab for 6 months compared with placebo on the percent changes in bone mineral density (BMD) at the lumbar spine, at the total hip and femoral neck in postmenopausal Chinese women with osteoporosis.

Medical Condition

Osteoporosis

Min. Age

55
Years

Max. Age

90
Years

Who Can Join?

Woman

Status

Active, not recruiting
Inclusion criteria
- Subject is considered reliable and capable of adhering to the protocol, visit schedule, and medication intake according to the judgment of the investigator - Subject is an ambulatory postmenopausal Chinese women, 55 to 90 years of age (inclusive) at the time of Screening. Postmenopause is defined as no spontaneous vaginal bleeding or spotting for 12 or more consecutive months prior to Screening - Subject has a bone mineral density (BMD) T-score ≤-2.50 at the lumbar spine, total hip, or femoral neck, as assessed by the central imaging vendor at the time of Screening based on DXA scans, and using data for Caucasian women from the National Health and Nutritional Examination Survey (NHANES, 1998) - Subject must have at least 1 of following independent risk factors for fracture: ● History of fragility fracture (except hip fracture, a severe vertebral fracture or more than 2 moderate vertebral fractures) ● Parental history of hip fracture ● Low body weight (body mass index ≤19kg/m2) ● Elderly (age ≥ 65 years) ● Current smoker - Subject has at least 2 vertebrae in the L1 to L4 region and at least 1 hip that are evaluable by dual-energy x-ray absorptiometry (DXA), as assessed by the central imaging vendor
Exclusion criteria
- Subject has a BMD T-score of ≤-3.50 at the total hip or femoral neck, as assessed by the central imaging vendor at the time of Screening based on DXA scans, and using data for Caucasian women from NHANES 1998 - Subject has a known history of hip fracture - Subject has any severe (SQ3) or more than 2 moderate (SQ2) vertebral fractures, as assessed by the central imaging vendor based on the lateral spine x-ray at Screening - Subject has a history of myocardial infarction (MI) - Subject has a history of stroke - Subject has a vitamin D insufficiency, defined as 25 (OH) vitamin D levels <20 ng/mL, as assessed by the central laboratory at Screening. Vitamin D repletion will be permitted and the subject may be retested once within the Screening Period - Subject has used oral bisphosphonates: ● Any doses received within 3 months prior to randomization ● More than 1 month of cumulative use between 3 and 12 months prior to randomization ● More than 3 years of cumulative use, unless the last dose was received ≥5 years prior to randomization - Subject has used intravenous (iv) bisphosphonates: ● zoledronic acid ◦ Any doses received within 3 years prior to randomization ◦ More than 1 dose received within 5 years prior to randomization ● iv ibandronate, iv pamidronate, or iv alendronate (ALN) ◦ Any doses received within 12 months prior to randomization ◦ More than 3 years of cumulative use, unless the last dose was received ≥5 years prior to randomization - Subject has used denosumab or any cathepsin K inhibitor: ● Any doses received within 18 months prior to randomization - Subject has used tibolone, cinacalcet, or calcitonin: ● Any doses received within 3 months prior to randomization - Subject has used teriparatide (TPTD) or any parathyroid hormone (PTH) derivative: ● Any doses received within 3 months prior to randomization ● More than 1 month of cumulative use between 3 and 12 months prior to randomization - Subject has used systemic oral or transdermal estrogen or selective estrogen receptor modulators (SERMs): ● More than 1 month of cumulative use within 6 months prior to randomization - Subject has used strontium ranelate or fluoride: ● More than 1 month of cumulative use within 5 years prior to randomization - Subject has used hormonal ablation therapy: ● More than 1 month of cumulative use within 6 months prior to randomization - Subject has used systemic glucocorticosteroids: ● ≥5mg prednisone equivalent per day for more than 14 days within 3 months prior to randomization - Subject has a history of osteonecrosis of the jaw (ONJ) or atypical femoral fracture (AFF) - Subject has evidence of any of the following: a. Current, uncontrolled hyper- or hypothyroidism. Uncontrolled hyperthyroidism is defined as thyroid-stimulating hormone (TSH) and thyroxine (T4) outside of the normal range. Uncontrolled hypothyroidism is defined as TSH >10 b. Current, uncontrolled hyperparathyroidism or history of hypoparathyroidism. Uncontrolled hyperparathyroidism is defined as PTH outside the normal range in subjects with concurrent hypercalcemia or PTH values >20 % above upper limit of normal (ULN) in normocalcemic subjects c. Current hypercalcemia or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range, as assessed by the central laboratory at the time of Screening. Albumin-adjusted serum calcium levels may be retested once in case of an elevated albumin-adjusted serum calcium level within 1.1xULN of the laboratory’s reference ranges d. Subject has ≥3xULN of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert’s syndrome). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert’s syndrome (ie, direct bilirubin <35 %)

Study Medication Description

Study Medication:

EVENITY

Other Descriptive Name:

romoszumab

Placebo

Yes

Comparator:

No

Study Dates

October 2021

Actual Start Date of Enrollment

December 2023

Planned Study Completion Date

General Information

Study ID:
OP0002
CT.gov Number:
NCT05067335
Phase:
Phase 3

Interested in enrolling in our study?

Just contact us

Austria

UCBCares.AT@ucb.com
+43 (0) 1 291 80 08
0800-296176 (freephone)

Belgium

UCBCares.BE@ucb.com
+32 2 559 92 00
0800 38 008 (freephone)
www.ucbcares.be

Bulgaria

Canada

+1 866 709 8444

Czech Republic

UCBCares.CZ@ucb.com
+420 221 773 442
800 144 395 (freephone)
www.ucbcares.cz

Denmark

UCBCares.DK@ucb.com
+45 32462480
80 253827 (freephone)
www.ucbcares.dk

Finland

UCBCares.FI@ucb.com
+358 942733300
0800 9 13353 (freephone)
www.ucbcares.fi

France

UCBCares.FR@ucb.com
+33 1 47 29 45 55
0 805 222 949 (freephone)
www.ucbcares.fr

Germany

Greece

UCBCares.GR@ucb.com
+30 21 0997 4200
0080 012 9910 (freephone)
www.ucbcares.gr

Hungary

UCBCares.HU@ucb.com
+36 1 472 5060
06 80 021 486 (freephone)
www.ucbcares.hu

Ireland

UCBCares.IE@ucb.com
+353 1 463 2371
1800 93 00 75 (freephone)
www.ucbcares.co.uk

Italy

UCBCares.IT@ucb.com
+39 02 3007 9300
8009-86932 (freephone)
www.ucbcares.it

Luxemburg

UCBCares.LU@ucb.com
+32 2 559 92 12
8002 3204 (freephone)

Norway

UCBCares.NO@ucb.com
+45 32462482
800-10101 (freephone)
www.ucbcares.no

Poland

UCBCares.PL@ucb.com
+48 22 596 97 97
00 800 121 68 25 (freephone)
www.ucbcares.pl

Portugal

UCBCares.PT@ucb.com
+351 213 025 300
800-8-56033 (freephone)

Romania

+4021 300 19 07

Slovakia

UCBCares.SK@ucb.com
+421 2 592 020 23
0800 002 566 (freephone)
www.ucbcares.sk

Spain

UCBCares.ES@ucb.com
+34 915 70 06 49
8000-99684 (freephone)
www.ucbcares.es

Sweden

UCBCares.SE@ucb.com
+45 32462481
0200 898 671 (freephone)
www.ucbcares.se

Switzerland

+41 58 822 3180

The Netherlands

UCBCares.NL@ucb.com
+31 76 573 1130
0800 3434335 (freephone)
www.ucbcares.nl

UK

UCBCares.UK@ucb.com
+44 1753 777 100
0800 279 3177 (freephone)
www.ucbcares.co.uk