Bone turnover markers as predictors of treatment break outcome

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003110-27-DK

Enrollment

140

Registered

2016-07-22

Start date

2016-10-03

Completion date

Unknown

Last updated

2019-12-10

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

Conditions

Osteoporosis MedDRA version: 19.0 Level: LLT Classification code 10031289 Term: Osteoporosis, unspecified System Organ Class: 100000004859

Interventions

Trade Name: Alendronate Product Name: Alendronate Product Code: M 05 BA 04 Pharmaceutical Form: Tablet INN or Proposed INN: bisphosphona

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: • Postmenopausal women (postmenopausal for at least two years) • Men above 50 years • Treatment for at least five years with alendronat • BMD T-score total hip > -2.5 • BMD T-score lumbar spine (L1-L4) > -4 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 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 140

Exclusion criteria

Exclusion criteria: Exclusion criteria: • Any low-energy fracture within the previous 5 years during alendronat treatment (not including fingers, toes, or skull) • Low-energy vertebral fracture at any time • Low-energy hip fracture at any time • Ongoing treatment with glucocorticoids • Metabolic bone disease • Hormone replacement therapy • Cancer • Other conditions affecting bone metabolism

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: To investigate to what extent changes in carboxy-terminal collagen crosslinks (CTX) 3 and 6 months after stopping alendronate treatment predict changes in total hip BMD after 1 year.; Primary end point(s): Primary endpoint: To investigate to what extent changes in carboxy-terminal collagen crosslinks (CTX) 3 and 6 months after stopping alendronate treatment predict changes in total hip BMD after 1 year. ; Main Objective: To investigate the predictive value of markers of bone turnover on bone loss 12 months after stopping alendronate therapy. Primary endpoint: To investigate to what extent changes in carboxy- terminal collagen crosslinks (CTX) 3 and 6 months after stopping alendronate treatment predict changes in total hip BMD after 1 year. ; Secondary Objective: Secondary endpoints: - To investigate to what extent baseline CTX when stopping alendronate treatment predicts changes in total hip BMD after 1 year. - To investigate to what extent changes in procollagen type I N- terminal propeptide (PINP) 3 and 6 months af-ter stopping alendronate treatment predict changes in total hip BMD after 1 year. - To investigate to what extent changes in the ratio CTX/PINP 3/6 months after stopping alendronate treatment predict changes in total hip BMD after 1 year. - The proportion of the study population in which bone turnover increases to above premenopausal/young adult reference levels after 3, 6, and 12 months. - The proportion of the study population who loses BMD beyond least significant change in lumbar spine and total hip.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: To investigate to what extent changes in carboxy-terminal collagen crosslinks (CTX) 3 and 6 months after stopping alendronate treatment predict changes in total hip BMD after 1 year.; Primary end point(s): Primary endpoint: To investigate to what extent changes in carboxy-terminal collagen crosslinks (CTX) 3 and 6 months after stopping alendronate treatment predict changes in total hip BMD after 1 year. ; Main Objective: To investigate the predictive value of markers of bone turnover on bone loss 12 months after stopping alendronate therapy. Primary endpoint: To investigate to what extent changes in carboxy- terminal collagen crosslinks (CTX) 3 and 6 months after stopping alendronate treatment predict changes in total hip BMD after 1 year. ; Secondary Objective: Secondary endpoints: - To investigate to what extent baseline CTX when stopping alendronate treatment predicts changes in total hip BMD after 1 year. - To investigate to what extent changes in procollagen type I N- terminal propeptide (PINP) 3 and 6 months af-ter stopping alendronate treatment predict changes in total hip BMD after 1 year. - To investigate to what extent changes in the ratio CTX/PINP 3/6 months after stopping alendronate treatment predict changes in total hip BMD after 1 year. - The proportion of the study population in which bone turnover increases to above premenopausal/young adult reference levels after 3, 6, and 12 months. - The proportion of the study population who loses BMD beyond least significant change in lumbar spine and total hip.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints: - To investigate to what extent baseline CTX when stopping alendronate treatment predicts changes in total hip BMD after 1 year. - To investigate to what extent changes in procollagen type I N- terminal propeptide (PINP) 3 and 6 months af-ter stopping alendronate treatment predict changes in total hip BMD after 1 year. - To investigate to what extent changes in the ratio CTX/PINP 3/6 months after stopping alendronate treatment predict changes in total hip BMD after 1 year. - The proportion of the study population in which bone turnover increases to above premenopausal/young adult reference levels after 3, 6, and 12 months. - The proportion of the study population who loses BMD beyond least significant change in lumbar spine and total hip. ; Timepoint(s) of evaluation of this end point: - To investigate to what extent baseline CTX when stopping alendronate treatment predicts changes in total hip BMD after 1 year. - To investigate to what extent changes in PINP 3 and 6 months af-ter stopping alendronate treatment predict changes in total hip BMD after 1 year. - To investigate to what extent changes in the ratio CTX/PINP 3/6 months after stopping alendronate treatment predict changes in total hip BMD after 1 year. - The proportion of the study population in which bone turnover increases to above premenopausal/young adult reference levels after 3, 6, and 12 months. - The proportion of the study population who loses BMD beyond least significant change in lumbar spine and total hip.	—

Measure

Time frame

Secondary end point(s): Secondary endpoints: - To investigate to what extent baseline CTX when stopping alendronate treatment predicts changes in total hip BMD after 1 year. - To investigate to what extent changes in procollagen type I N- terminal propeptide (PINP) 3 and 6 months af-ter stopping alendronate treatment predict changes in total hip BMD after 1 year. - To investigate to what extent changes in the ratio CTX/PINP 3/6 months after stopping alendronate treatment predict changes in total hip BMD after 1 year. - The proportion of the study population in which bone turnover increases to above premenopausal/young adult reference levels after 3, 6, and 12 months. - The proportion of the study population who loses BMD beyond least significant change in lumbar spine and total hip. ; Timepoint(s) of evaluation of this end point: - To investigate to what extent baseline CTX when stopping alendronate treatment predicts changes in total hip BMD after 1 year. - To investigate to what extent changes in PINP 3 and 6 months af-ter stopping alendronate treatment predict changes in total hip BMD after 1 year. - To investigate to what extent changes in the ratio CTX/PINP 3/6 months after stopping alendronate treatment predict changes in total hip BMD after 1 year. - The proportion of the study population in which bone turnover increases to above premenopausal/young adult reference levels after 3, 6, and 12 months. - The proportion of the study population who loses BMD beyond least significant change in lumbar spine and total hip.

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Countries

Denmark

Contacts

Public ContactBente Lomholt Langdahl

Dept. of Endocrinology and Internal Medicine, Aarhus University Hospital

benlan@rm.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026