Health TrialsbyHealthPanel

Sequential Therapies After Osteoanabolic Treatment

ConditionOsteoporosis, Postmenopausal
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age50-85
Sponsor424 General Military Hospital

About this trial

12-month prospective, open-label, multicenter, international, observational study evaluating sequential treatments after osteoanabolics

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

a bone disease other than postmenopausal osteoporosis

use of medications other than romosozumab or teriparatide affecting bone metabolism during the last 12 months before entering the study

creatinine clearance <60 mL/min/1.73 m2

liver failure

Trial population

Postmenopausal women treated with severe osteoporosis

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Zoledronate

    Drug

    intravenous infusion

  • Denosumab

    Drug

    subcutaneous injection

  • Teriparatide

    Drug

    subcutaneous injection

  • Romosozumab

    Drug

    subcutaneous injection

  • Abaloparatide Injection (80 mcg)

    Drug

    daily subcutaneous injection

Treatment groups

150 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Romo-Zol group1 intervention
Group B: Romo-Dmab group1 intervention
Group C: Romo-PTH group2 interventions
Group D: PTH-Zol group1 intervention
Group E: PTH-Dmab group1 intervention
Group F: TPTD-Romo group1 intervention

Trial outcomes

Primary outcomes

1

lumbar spine bone mineral density

bone mineral density changes at the lumbar spine at 12 months measured by dual-energy absorptiometry (DXA)

Time frame
baseline to 12 months

Secondary outcomes

1

femoral neck bone mineral density

bone mineral density changes at the femoral neck at 12 months measured by dual-energy absorptiometry (DXA)

Time frame
baseline to 12 months
2

total hip bone mineral density

bone mineral density changes at the total hip at 12 months measured by dual-energy absorptiometry (DXA)

Time frame
baseline to 12 months
3

P1NP

bone turnover (formation) marker

Time frame
baseline, 3 months, 6 months, 12 months
4

CTx

bone turnover (resorption) marker

Time frame
baseline, 3 months, 6 months, 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

424 General Military Hospital

Lead sponsor

Source ClinicalTrials.gov
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