---
title: Study to Investigate if Adding Lactulose to Vitamin D and Calcium Has an Effect on the Preservation of Bone in Postmenopausal Women
nct_id: NCT00160264
overall_status: COMPLETED
phase: PHASE4
sponsor: Solvay Pharmaceuticals
study_type: INTERVENTIONAL
primary_condition: Osteopenia
countries: Spain
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00160264.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00160264"
ct_last_update_post_date: 2009-01-30
last_seen_at: "2026-05-12T07:23:30.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study to Investigate if Adding Lactulose to Vitamin D and Calcium Has an Effect on the Preservation of Bone in Postmenopausal Women

**Official Title:** A Randomized, Double-Blind, Multicenter, Parallel Pilot Clinical Trial to Study the Efficay of a Treatment of Lactulose + Vitamin D + Calcium 0.5 g Concurrently Controlled With a Standard Treatment (Vit D + Calcium) in Bone Mass Preservation Among Postmenopausal Women

**NCT ID:** [NCT00160264](https://clinicaltrials.gov/study/NCT00160264)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 40
- **Lead Sponsor:** Solvay Pharmaceuticals
- **Conditions:** Osteopenia
- **Start Date:** 2003-01
- **CT.gov Last Update:** 2009-01-30

## Brief Summary

This is a randomized, double-blind, multicentre, parallel pilot clinical trial to study the efficacy of a treatment of lactulose 15 ml + vitamin D 400 U + calcium 0.5 g compared to lactulose placebo 15 ml + vitamin D 400 U + calcium 1 g in bone mass preservation among postmenopausal women.

## Eligibility

- **Minimum age:** 55 Years
- **Maximum age:** 65 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

Women aged between 55 and 65 years old; postmenopausal who have amenorrhea for 5 or more years; women with the diagnosis of osteopenia defined DMO -1,5 to -2,5

Exclusion Criteria:

Any disease causing osteopenia (hyperthyroidism, hyperparathyroidism, hypercortisolism, osteogenesis imperfecta, rheumatoid arthritis, homocystinuria, etc.)
```

## Interventions

- **Lactulose, Vitamin D, Calcium** (DRUG)

## Primary Outcomes

- **bone mass preservation by bone densitometry values in 1 year period**

## Secondary Outcomes

- **evolution of bone remodelling parameters**

## Locations (3)

- Site 1, Barcelona, Spain
- Site 2, Barcelona, Spain
- Site 3, Barcelona, Spain

## Recent Field Changes (last 30 days)

- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.site 1|barcelona||spain` — added _(2026-05-12)_
- `locations.site 2|barcelona||spain` — added _(2026-05-12)_
- `locations.site 3|barcelona||spain` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00160264.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00160264*  
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