---
title: Changes in Bone Mineral Density and Fracture Risk in Patients Receiving Androgen Deprivation Therapy for Prostate Cancer
nct_id: NCT00536653
overall_status: COMPLETED
phase: NA
sponsor: Wirral University Teaching Hospital NHS Trust
study_type: INTERVENTIONAL
primary_condition: Osteoporosis
countries: United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00536653.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00536653"
ct_last_update_post_date: 2007-09-28
last_seen_at: "2026-05-12T07:11:27.013Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Changes in Bone Mineral Density and Fracture Risk in Patients Receiving Androgen Deprivation Therapy for Prostate Cancer

**Official Title:** Long Term Changes in Bone Mineral Density and Fracture Risk in Patients Receiving Androgen Deprivation Therapy for Advanced Prostate Cancer, With Stratification of Treatment Based on Presenting Values

**NCT ID:** [NCT00536653](https://clinicaltrials.gov/study/NCT00536653)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 618
- **Lead Sponsor:** Wirral University Teaching Hospital NHS Trust
- **Conditions:** Osteoporosis
- **Start Date:** 1999-10
- **Completion Date:** 2007-01
- **CT.gov Last Update:** 2007-09-28

## Brief Summary

The aim of this study is to determine the long term effects of two types of hormonal treatment for advanced prostate cancer (LHRH agonists and the antiandrogen bicalutamide)on the bone mineral density of patients.

## Detailed Description

Androgen ablation is the mainstay of treatment for advanced prostate cancer. However,luteinizing hormone-releasing (LHRH) agonists are associated with accelerated bone loss, osteoporosis and fractures. An alternative is the non steroidal antiandrogen, bicalutamide, which acts at the androgen receptor and maintains serum testosterone levels. Our aim was to assess the effects of these two treatments on bone mineral density (BMD) of selected groups of patients, based on their BMD at presentation. All patients will undergo peripheral bone densitometry of the forearm, using dual energy X-ray absorptiometry. Osteoporotic patients, at high risk of fractures, will be commenced on bicalutamide. Osteopenic and normal BMD patients will be commenced on LHRH agonists. All osteopenic and osteoporotic patients will be given calcium and vitamin D supplementation.Patients will undergo annual bone densitometry scans, and will be seen in the clinic every 3 months to monitor well-being and PSA levels. Any patient who fails to respond or escapes treatment with hormone monotherapy will be managed according to the clinical situation by either being switched to a combination of LHRH and bicalutamide or additional oestrogen therapy.

## Eligibility

- **Sex:** MALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Patients will locally advanced prostate cancer for whom immediate androgen deprivation was indicated

Exclusion Criteria:

* Previous systemic therapy for prostate cancer
* Patients with any illness or medication that would affect bone and mineral metabolism
* Severe hepatic or renal insufficiency
```

## Arms

- **Osteporosis Group** (ACTIVE_COMPARATOR) — Patients with a presenting T score \< -2.5 (osteoporosis), treated with bicalutamide and Ca/VitD
- **Osteopenia Group** (ACTIVE_COMPARATOR) — Patients with a presenting T score between -1.0 and -2,4 (osteopenia), treated with LHRH agonists and Ca/VitD
- **Normal Group** (ACTIVE_COMPARATOR) — Patients with a presenting T score \> -1.0(normal BMD), treated with LHRH agonists

## Interventions

- **Bicalutamide and Calcium/ Vitamin D supplementation** (DRUG) — Bicalutamide 150mg once daily, Calcium and Vitamin D supplementation once daily
- **LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementation** (DRUG) — 3 monthly depot injection of LHRH agonist (Goserelin acetate 10.8mg) and Calcium/ Vitamin D supplementation daily
- **LHRH agonists (Goserelin acetate)** (DRUG) — 3 monthly depot injection of LHRH agonists (Goserelin acetate 10.8mg)

## Primary Outcomes

- **Peripheral Forearm bone mineral density** _(time frame: Over 7 years)_

## Secondary Outcomes

- **Fractures of the thoracolumbar spine** _(time frame: Over 7 years)_

## Locations (1)

- Wirral University Hospitals NHS Trust, Upton, Wirral, Merseyside, United Kingdom

## Recent Field Changes (last 30 days)

- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.wirral university hospitals nhs trust|upton, wirral|merseyside|united kingdom` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT00536653*  
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