Study of 4 Bone Turnover Markers in Patients With Multiple Myeloma Treated With Intravenous Bisphosphonate in Routine Care

Assessment of 4 Bone Turnover Markers (C-terminal Telopeptides of Type I Collagene (CTX), Amino-terminal Telopeptide of Type 1 Collagen (NTX), Dickkopf-1 (DKK-1) and Sclerostin (SOST)) in Multiple Myeloma Patients Treated With Intravenous Bisphosphonate

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04111809

Acronym

AMBROBiMM

Enrollment

Registered

2019-10-01

Start date

2020-09-29

Completion date

2020-10-20

Last updated

2025-09-25

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

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma, intravenous bisphosphonate, bone markers

Brief summary

The aim of this study is looking at the Kinetics of bone turnover markers (C-terminal telopeptides of type I collagene (CTX), amino-terminal telopeptide of type 1 collagen (NTX), Dickkopf-1 (DKK-1) and Sclerostin (SOST)) in serum and urine until 12 months in Patients with Multiple Myeloma Treated With intravenous bisphosphonates in routine care.

Interventions

BIOLOGICALBlood and urine collection

collected 10 mL of blood and 15 mL of urine every 2 months until 12 months

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Patient aged 65 to 75 years of age 2. Patient with symptomatic multiple myeloma as defined by the criteria of the IMWG 3. Need to introduced an antiresorptive bone treatment by intravenous bisphosphonate with bone imaging mapping (PET-scanner preferentially) in routine care 4. Ability and willingness to follow scheduled visits with requested biological samples

Exclusion criteria

\- Patients previously treated with intravenous biphosphonate

Design outcomes

Primary

Measure	Time frame	Description
Changes in bone turnover markers	Baseline, then every 2 months in 12 months	bone turnover markers include: C-terminal telopeptides of type I collagene (CTX) in serum, amino-terminal telopeptide of type 1 collagen (NTX) in urine, Dickkopf-1 (DKK-1) and Sclerostin (SOST) in plasma

Secondary

Measure	Time frame	Description
Doses of intravenous bisphosphonate	Up to 12 months	To study the relationship between doses and bone turnover markers
Rate of intravenous bisphosphonate	Up to 12 months	To study the relationship between doses and bone turnover markers
evolution of bone lesions by imaging	Up to 12 months	evolution of bone lesions by imaging
time to maximum variation of bone turnover markers	Baseline, then every 2 months in 12 months	CTX, NTX, DKK-1 and SOST
Number of adverse events likely to be related to bisphosphonate	Up to 12 months	—
Changes in Monoclonal protein	Baseline, then every 2 months in 12 months	To evaluated response to treatment
Number of new bone events	Up to 12 months	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026